510(k) K241091
- Device
- SIMEOX 200 Airway Clearance Device
- Applicant
- Inogen, Inc.
- 510(k) number
- K241091
- Product code
- SDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-23
- Date received
- 2024-04-22
- Regulation
- 868.5665
- Classification name
- Intra-Pulmonary Percussive Vibration (Ipv) Devices
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carole Harris
- Address
- 859 Ward Dr. Suite 200 Goleta CA US 93111 93111
FDA Registration Numbers#
- 3019385742
- 3007858792
- 3011120183
- 3018783526
- 3000126629
- 3004672275
- 3023272766
- 3019585099
- 2518422