510(k) K932187
K932187 is an FDA 510(k) premarket notification submitted by Voss Medical Products for the device "PRONE POSITIONER". The FDA issued a decision of Substantially Equivalent on June 1, 1993. The device falls under product code KIL (Positioner, Socket), a Class I device regulated under 21 CFR 888.4540. Voss Medical Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1993
- Date Received
- May 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Positioner, Socket
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type