510(k) K002159
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2002
- Date Received
- July 17, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type