510(k) K810991
K810991 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "HEADSTRAP". The FDA issued a decision of Substantially Equivalent on Apr 29, 1981. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 1981
- Date Received
- Apr 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strap, Head, Gas Mask
- Device Class
- Class I
- Regulation Number
- 868.5560
- Review Panel
- AN
- Submission Type