510(k) clearances

AT-Patch (ATP-C130/ATP-C70)

Atsens Co., Ltd. · Cardiovascular

K242583Substantially EquivalentTraditionalDSH
Open FDA's page for this record
Third party flag
N
City
Seongnam-Si
Advisory committee description
Cardiovascular
Address 1
Pt. Town 803, 11, Gumi-Ro, Bundang-Gu,
Address 2
Seongnam-Si, Gyeonggi-Do
Statement or summary
Summary
Product code
DSH
Zip code
13637
Applicant
Atsens Co., Ltd.
Decision date
2025-05-02
Decision code
SESE
Country code
KR
Device name
AT-Patch (ATP-C130/ATP-C70)
Advisory committee
CV
Contact
KeonHoon Lee
K number
K242583
Date received
2024-08-30
Review advisory committee
CV
Postal code
13637
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Recorder, Magnetic Tape, Medical
Medical specialty description
Cardiovascular
Regulation number
870.2800
Device class
2
Registration number
3009499478, 3004009431, 8030978, 3007663004, 3009077524, 3013500228, 3042167640, 3014929383, 3008773647, 3016812424, 3006733253, 3014226707, 3014271754, 3024821700, 3003584029, 3046311522, 3026042935, 3013889955, 3006087789, 1527715, 3021769057, 2133409, 3024673, 3004035727, 3014848734, 3030721635, 3003263092, 3010342616, 1218950, 3010576710, 3010082909, 3016701404, 3014522540, 3014111150, 2017865, 3043479346, 3006258337, 3000126629, 3010381606, 3030310221 +17 more
FEI number
3009499478, 3004009431, 3007663004, 3009077524, 3013500228, 3042167640, 3014929383, 3008773647, 3016812424, 3006733253, 3014226707, 3014271754, 3024821700, 3003584029, 3046311522, 3026042935, 3013889955, 3006087789, 1527715, 3021769057, 3024673, 3004035727, 3014848734, 3030721635, 1000520785, 3003263092, 3010342616, 1218950, 3010576710, 3002807167, 3003708031, 3010082909, 3016701404, 3014522540, 3014111150, 2017865, 3043479346, 1000140026, 3002808182, 3006258337 +17 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.