510(k) K962528
K962528 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "OLYMPUS MOBILE CHAIR/COUCH". The FDA issued a decision of Substantially Equivalent on December 12, 1996. The device falls under product code FZK (Chair, Surgical, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Keymed (Medical & Industrial Equipment), Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1996
- Date Received
- June 27, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Surgical, Non-Electrical
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type