Self-Contained Mobile Ophthal. Oper. .
FDA 510(k) K822427 · Surgi-Quip Inc.U
510(k) numberK822427
Submission
- Device name
- Self-Contained Mobile Ophthal. Oper. .
- Applicant
- Surgi-Quip Inc.U
Mchenry, IL, US - Received
- August 12, 1982
- Decision date
- September 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSE – Table, Operating-Room, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860503 | The Porex Retractor TableFSE · Traditional | Porex Medical | 03/13/1986SE |
| K843801 | Mason Equipment Organizer & AspenFSE · Traditional | Aspen Laboratories, Inc. | 10/25/1984SE |
| K840027 | Operating Room StandFSE · Traditional | Healthmate, Inc. | 02/04/1984SE |
| K831042 | Chemonucleolysis Table ExtensionFSE · Traditional | Orthopedic Systems, Inc. | 05/16/1983SE |
| K830339 | Imsi/Metripond Hand Operating TableFSE · Traditional | Intl. Management Services, Inc. | 04/12/1983SE |
| K821924 | Table, Operating, Field 6530-00-709-8155FSE · Traditional | Emerson-Sack-Warner Corp. | 07/13/1982SE |
| K801382 | Disposable Surgical Head SupportFSE · Traditional | Innovative Surgical Products, Inc. | 06/26/1980SE |
| K782092 | Armboard Cver, DisposableFSE · Traditional | Anago, Inc. | 01/10/1979SE |
| K780868 | Chest RollsFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
| K780867 | Pad Holder KitFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
More from Devon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841116 | Mobile Ophthalmic Operating TableFWX · Traditional | 05/09/1984SE |
| K841115 | Charles/Mcintyre Giant Break TableFQO · Traditional | 05/09/1984SE |
| K840004 | Wee Bag O'MercuryLCC · Traditional | 03/22/1984SE |
| K832887 | Electronic UnitEPT · Traditional | 10/04/1983SE |
| K822554 | Cement Extraction Instrumentation · Traditional | 09/14/1982SE |
| K822428 | Surgi-Quip Microscope StandHBN · Traditional | 09/02/1982SE |
| K822426 | Mcintyre Microscope StandHBN · Traditional | 09/02/1982SE |
Questions and answers
When was Self-Contained Mobile Ophthal. Oper. . cleared by the FDA?
Self-Contained Mobile Ophthal. Oper. . (K822427) received a 510(k) decision of Substantially Equivalent on September 14, 1982, 33 days after the submission was received.
What is the product code of K822427?
The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.