HM-0970
FDA 510(k) K932720 · Hill-Med, Inc.
510(k) numberK932720
Submission
- Device name
- HM-0970
- Applicant
- Hill-Med, Inc.
Miami, FL, US - Received
- June 4, 1993
- Decision date
- September 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | Marco Ophthalmic, Inc. | 07/22/1993SE |
| K920641 | Alcon Operating MicroscopesHRM · Traditional | Alcon Laboratories | 10/09/1992SE |
| K914956 | Keeler Konan Specular Microscope SP5500HRM · Traditional | Keeler Instruments, Inc. | 02/03/1992SE |
| K891584 | S 22 Instrument StandHRM · Traditional | Carl Zeiss, Inc. | 06/08/1989SE |
| K891001 | Microscope Knob Cover, Sterile, DisposableHRM · Traditional | Prescott'S, Inc. | 04/11/1989SE |
| K854440 | Modified Clinical Widefield Specular Microscope 50HRM · Traditional | Keeler Instruments, Inc. | 12/16/1985SE |
| K853855 | Xtal X-150 Operating MicroscopeHRM · Traditional | Xtal Corp. | 10/15/1985SE |
| K852586 | Cromic Surgical Microscope Model MC-1HRM · Traditional | Seltrex, Corp. | 07/30/1985SE |
| K852150 | Clinical Widefield Specular Micriscope 500HRM · Traditional | Keeler Instruments, Inc. | 06/03/1985SE |
| K850270 | Corneal Light ShieldHRM · Traditional | Mentor O & O, Inc. | 05/31/1985SE |
More from Mentor O & O, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993991 | HM-930 Electrosurgical UnitGEI · Traditional | 05/30/2000SE |
| K981781 | Electrosurgical UnitGEI · Traditional | 12/04/1998SE |
| K961473 | HM-88011 Solid State Electr Surgical UnitGEI · Traditional | 05/07/1996SE |
| K951718 | Hm-SpiroBZG · Traditional | 12/20/1995SE |
| K940140 | Hm-CryoGEH · Traditional | 06/27/1994SE |
| K932896 | HM-0690 ColposcopeHEX · Traditional | 03/23/1994SE |
| K932782 | HM-0660HEX · Traditional | 03/23/1994SE |
| K932817 | HM-880 IGEI · Traditional | 03/09/1994SE |
| K932818 | HM-880GEI · Traditional | 02/25/1994SE |
Questions and answers
When was HM-0970 cleared by the FDA?
HM-0970 (K932720) received a 510(k) decision of Substantially Equivalent on September 7, 1993, 95 days after the submission was received.
What is the product code of K932720?
The FDA product code is HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 878.4700.