ELECTRIC INSTRUMENT TABLE
FDA 510(k) clearance K832073 · decided 1983-08-12
Clearance details
- K-number
- K832073
- Device name
- ELECTRIC INSTRUMENT TABLE
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-28
- Decision date
- 1983-08-12
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- HMF
- Device class
- 1
- Regulation number
- 886.1860
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- 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 |
|---|---|---|
| ROTA SYSTEM 5000 (K935952) | Rota Systems Medfurniture, Inc. | 1994-04-19 |
| ROTA DATAMATE I (K935945) | Rota Systems,Inc. | 1994-04-19 |
| ROTA SYSTEM XL (K931839) | Rota Systems Medfurniture, Inc. | 1993-11-22 |
| MARCO INTERNATIONAL STAND (K930440) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON OPHTHALMIC STAND - MODEL XL3200 (K924771) | R.H. Burton Co. | 1993-04-05 |
| BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (K924780) | R.H. Burton Co. | 1993-04-05 |
| OPHTHALMIC STAND (K913961) | Luneau Ophtalmologie SA | 1991-12-04 |
| RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358) | Dentsply Intl. | 1985-10-04 |
| OPHTHALMIC CHAIR (K844362) | Luneau Laboratories | 1984-12-11 |
| OPHTHALMIC STAND (K844363) | Luneau Laboratories | 1984-12-05 |
| RELIANCE OPHTHALMIC INSTRUMENT CONTROL (K812544) | F. & F. Koenigkramer | 1981-09-21 |
| SYSTEM 1 INSTRUMENT STAND (K803195) | Surgical Mechanical Research, Inc. | 1981-02-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |