510(k) K873498
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1988
- Date Received
- August 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Airway Pressure (Inspiratory Force)
- Device Class
- Class II
- Regulation Number
- 868.1780
- Review Panel
- AN
- Submission Type