SIMEOX 200 Airway Clearance Device— 510(k) K241091
Substantially EquivalentInogen, Inc.
FDA 510(k) clearance K241091 for SIMEOX 200 Airway Clearance Device, Substantially Equivalent on 2024-12-23. Applicant: Inogen, Inc.. Device class: 2.
Clearance details
- Applicant
- Inogen, Inc.
- Product code
- Code SDT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5665
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
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