510(k) K854537
K854537 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "HEADSTRAP". The FDA issued a decision of Substantially Equivalent on December 3, 1985. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1985
- Date Received
- November 13, 1985
- 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