Product code LFF
- Device name
- Unit, Activation, Breath Control
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3920
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964977 | IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) | Interactive Living Systems, Inc. | 1998-08-31 |