Emergency Power Pac (Empac)
FDA 510(k) K813273 · Optical Micro Systems, Inc.
510(k) numberK813273
Submission
- Device name
- Emergency Power Pac (Empac)
- Applicant
- Optical Micro Systems, Inc.
Mchenry, IL, US - Received
- November 20, 1981
- Decision date
- December 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKP – Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code HKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952558 | Aaron Vac 2HKP · Traditional | Aaron Medical Industries | 03/19/1997SE |
| K950056 | The Grieshaber Axial CutterHKP · Traditional | Grieshaber & Co. | 05/05/1995SE |
| K950287 | Univit ProbeHKP · Traditional | Medical Instrument Development Laboratories, Inc. | 04/10/1995SE |
| K896622 | Visitec Vitrectomy UnitHKP · Traditional | Visitec Co. | 04/04/1990SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | Mentor O & O, Inc. | 04/17/1989SE |
| K832074 | Cavitron/Kelman Phaco-Emulsifier AspiraHKP · Traditional | CooperVision, Inc. | 08/01/1983SE |
| K822599 | Keates I/A System Frigitronics 4000HKP · Traditional | Frigitronics of Connecticut, Inc. | 10/06/1982SE |
| K810152 | X-VeeHKP · Traditional | Temporaty Surgical Systems | 03/17/1981SE |
| K801231 | Eye-VacHKP · Traditional | Coburn Optical Ind., Inc. | 07/21/1980SE |
| K791898 | Ocutome Model 8000HKP · Traditional | Cooper Medical Devices Corp. | 10/30/1979SE |
More from Cooper Medical Devices Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | 07/11/1995SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | 03/14/1994SE |
| K935226 | I/V PoleKYG · Traditional | 02/16/1994SE |
| K935003 | Electric I/V Pole or EIVP2KYG · Traditional | 01/25/1994SE |
| K870068 | Aspiration Reversal Control (Arc) ModuleHQE · Traditional | 02/12/1987SE |
| K844373 | O.M.S. Ultra-PhacoHQC · Traditional | 12/19/1985SE |
| K844448 | Oms/Gonvers Retinal PerforatorHNM · Traditional | 08/21/1985SE |
| K844895 | Oms Silicone Oil InjectorLWL · Traditional | 06/24/1985SE |
| K844467 | Oms Cryo · Traditional | 02/22/1985SE |
Questions and answers
When was Emergency Power Pac (Empac) cleared by the FDA?
Emergency Power Pac (Empac) (K813273) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 41 days after the submission was received.
What is the product code of K813273?
The FDA product code is HKP – Instrument, Vitreous Aspiration And Cutting, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.