HRM — Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class I
FDA product code HRM covers "Microscope, Operating & Accessories, Ac-Powered, Ophthalmic", a Class I medical device regulated under 21 CFR 878.4700. Submissions are reviewed by the General, Plastic Surgery panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HRM
- Device Class
- Class I
- Regulation Number
- 878.4700
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K932720 | hill-med | HM-0970 | September 7, 1993 |
| K930439 | marco ophthalmic | MARCO SURGISCOPE OPERATION MICROSCOPES | July 22, 1993 |
| K920641 | alcon laboratories | ALCON OPERATING MICROSCOPES | October 9, 1992 |
| K914956 | keeler instruments | KEELER KONAN SPECULAR MICROSCOPE SP5500 | February 3, 1992 |
| K891584 | carl zeiss | S 22 INSTRUMENT STAND | June 8, 1989 |
| K891001 | prescott | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | April 11, 1989 |
| K854440 | keeler instruments | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 | December 16, 1985 |
| K853855 | xtal | XTAL X-150 OPERATING MICROSCOPE | October 15, 1985 |
| K852586 | seltrex | CROMIC SURGICAL MICROSCOPE MODEL MC-1 | July 30, 1985 |
| K852150 | keeler instruments | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 | June 3, 1985 |
| K850270 | mentor o and o | CORNEAL LIGHT SHIELD | May 31, 1985 |
| K844323 | keeler instruments | KONAN CLINIC MICROSCOPE CLM-100-150 | November 21, 1984 |
| K822563 | treace medical | OPHTHALMIC MICROSCOPE | September 14, 1982 |
| K792083 | lumenis | HAAG-STREIT SLIT LAMP 900 | November 16, 1979 |