510(k) K780037
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1978
- Date Received
- January 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Therapeutic (Incentive)
- Device Class
- Class II
- Regulation Number
- 868.5690
- Review Panel
- AN
- Submission Type