Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
Shenzhen Xinyan Medical Technology Co.,ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Cardiovascular
- Address 1
- 1st Bldg.,501-1&501-2,Mitehua&Pukyo Bio Science Park
- Address 2
- Jinxiu E. Rd.,Laokeng Comm.,Longtian St.,Pings Dist.
- Statement or summary
- Summary
- Product code
- MWJ
- Zip code
- 518122
- Applicant
- Shenzhen Xinyan Medical Technology Co.,ltd.
- Decision date
- 2026-09-11
- Decision code
- SESE
- Country code
- CN
- Advisory committee
- CV
- Contact
- Zhang Haibo
- K number
- K254119
- Date received
- 2025-12-19
- Review advisory committee
- CV
- Postal code
- 518122
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
- Harmonized identifiers (openFDA)
- Device name
- Electrocardiograph, Ambulatory (Without Analysis)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2800
- Device class
- 2
- Registration number
- 3009443693, 3016701404, 1316463, 1000165971, 3014848734, 3010844918, 3008413470, 8030978, 1224919, 1527715, 3015185344, 3008977358, 3008717264, 3007770164, 3013889955, 3009077524, 3010222749, 3035371769, 3016618143, 1218950, 2028530, 3014235520, 3013596024, 3007184699, 3004009431, 9610816, 3004006614, 3012027770, 3016406615, 3006087789, 3010082909, 3009499478, 9611295, 9681548, 3032906215, 3015529350, 3010381606, 3012528160, 1000122786, 3003971136 +11 more
- FEI number
- 3009443693, 3016701404, 1316463, 1000165971, 3014848734, 1000263641, 3010844918, 3008413470, 1527715, 3015185344, 3008977358, 3002807992, 3008717264, 3007770164, 3013889955, 3009077524, 3010222749, 3035371769, 1000513706, 3016618143, 1218950, 3002808182, 3014235520, 3002807745, 3013596024, 3007184699, 3004009431, 1000125122, 3004006614, 3012027770, 3016406615, 3006087789, 3002807167, 3010082909, 3009499478, 3000203466, 3032906215, 3015529350, 3010381606, 3012528160 +11 more