MOBILE OPERATING TABLE FOR ORL MICROSURGERY
FDA 510(k) clearance K853720 · decided 1985-10-18
Clearance details
- K-number
- K853720
- Device name
- MOBILE OPERATING TABLE FOR ORL MICROSURGERY
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-05
- Decision date
- 1985-10-18
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GDC
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Thornwood, NY, 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 |
|---|---|---|
| QUANTUM 3080SP SURGICAL TABLE (K971390) | STERIS Corporation | 1997-05-15 |
| MOBILE OPERATING TABLE 1132.01 (K970807) | Stierlen-Maquet AG | 1997-03-14 |
| DURA-BOARD ARMBOARD (K964273) | Allen Medical Systems, Inc. | 1997-01-08 |
| SKYTRON ELITE 3500 TABLE (K940616) | Skytron, Div. the Kmw Group, Inc. | 1994-06-13 |
| MIDMARK MAGNUM GENERAL SURGICAL TABLE (K934744) | Midmark Corp. | 1994-03-28 |
| MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (K914758) | Mdt Corp., Inc. | 1991-12-19 |
| MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (K915393) | Mdt Corp., Inc. | 1991-12-17 |
| OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (K883613) | Stierlen-Maquet AG | 1988-09-15 |
| SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (K853480) | Skytron, Div. the Kmw Group, Inc. | 1985-09-12 |
| TRAUMA TABLE (K853535) | Xre Corp. | 1985-09-11 |
| MAYFIELD TABLE-ELECTRIC (K851021) | Ohio Medical Instrument Co., Inc. | 1985-05-21 |
| SKYTRON ELITE 7000 MICRO-SURGERY TABLE (K851830) | Skytron, Div. the Kmw Group, Inc. | 1985-05-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |