510(k) K853785
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1985
- Date Received
- September 10, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Gas, Anesthetic
- Device Class
- Class I
- Regulation Number
- 868.5550
- Review Panel
- AN
- Submission Type