OLYMPUS MOBILE CHAIR/COUCH
FDA 510(k) clearance K962528 · decided 1996-12-12
Clearance details
- K-number
- K962528
- Device name
- OLYMPUS MOBILE CHAIR/COUCH
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-27
- Decision date
- 1996-12-12
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- FZK
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Southend-On-Sea, Essex, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEUTRAL POS-CHAIR SURGEON CHAIR (K842030) | Neutral Pos-Chair Co. | 1984-07-23 |
Recalls involving this device
No recalls on record reference this clearance.