ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Amptron Medical, Inc. · Anesthesiology
Open FDA's page for this record- Third party flag
- N
- City
- Carlsbad
- Advisory committee description
- Anesthesiology
- Address 1
- 2231 Faraday Ave.,
- Address 2
- Suite 130
- Statement or summary
- Summary
- Product code
- BZK
- Zip code
- 92008
- Applicant
- Amptron Medical, Inc.
- Decision date
- 2026-09-16
- Decision code
- SESE
- Country code
- US
- Device name
- ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
- Advisory committee
- AN
- Contact
- Nirav Patel
- K number
- K260226
- State
- CA
- Date received
- 2026-01-26
- Review advisory committee
- AN
- Postal code
- 92008
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Spirometer, Monitoring (W/Wo Alarm)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.1850
- Device class
- 2
- Registration number
- 3016490024, 3023272766, 3006606827, 3006783791, 3008483389, 3005877899, 3008264255, 3013557562, 3005783425, 3009156722, 9610105, 3013679558, 3017200972, 3004415070, 1000604079, 3016618143, 9710602, 1722070, 3006254047, 3007603826, 3016509761, 1219324, 3013596024, 3021559257, 3009499478, 3000126629, 2022648, 3018783526, 3030446844, 3003971136, 1651104, 3013500228, 3013853674, 3008729547, 3014541700, 8043316, 2024500, 2430863
- FEI number
- 3016490024, 1000117260, 3023272766, 3006606827, 3006783791, 3008483389, 3005877899, 3008264255, 3013557562, 3005783425, 3009156722, 3013679558, 3017200972, 3004415070, 1000604079, 3016618143, 3006254047, 3007603826, 3016509761, 1219324, 3013596024, 3003513129, 3021559257, 3009499478, 3000126629, 2022648, 3018783526, 3030446844, 3003971136, 3003319165, 3013500228, 3013853674, 3008729547, 3014541700, 2024500, 3002737156, 2430863, 3002806783