510(k) clearance
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
- 510(k) number
- K260226
- Applicant
- Amptron Medical, Inc.
- Decision date
- Sep 16, 2026
- Date received
- Jan 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- BZK
- Device type
- Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II
- Regulation
- 21 CFR 868.1850
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Carlsbad, CA, US