MOBILE OPHTHALMIC OPERATING TABLE
FDA 510(k) clearance K841116 · decided 1984-05-09
Clearance details
- K-number
- K841116
- Device name
- MOBILE OPHTHALMIC OPERATING TABLE
- Applicant
- Surgi-Quip Inc.U
- Decision
- Substantially Equivalent
- Date received
- 1984-03-15
- Decision date
- 1984-05-09
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- FWX
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- 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 |
|---|---|---|
| ALM OPERATING TABLES (K884019) | Alm Surgical Equipment, Inc. | 1988-10-13 |
| TABLE, OPERATING, FIELD 6530-00-709-8175 (K821923) | Emerson-Sack-Warner Corp. | 1982-07-13 |
Recalls involving this device
No recalls on record reference this clearance.