510(k) K831008
K831008 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "HEAD STRAP". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Medovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- March 30, 1983
- 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