HKM — Retinoscope, Battery-Powered Class I
FDA product code HKM covers "Retinoscope, Battery-Powered", a Class I medical device regulated under 21 CFR 886.1780. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HKM
- Device Class
- Class I
- Regulation Number
- 886.1780
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964338 | rudolf riester gmbh and co. kg | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | January 9, 1997 |
| K950791 | neitz instruments company | STREAK RETINOSCOPE RX-3 | March 28, 1995 |
| K950794 | neitz instruments company | STREAK RETINOSCOPE RX-RC | March 28, 1995 |
| K950792 | neitz instruments company | STREAK RETINOSCOPE RX-3A | March 28, 1995 |
| K950793 | neitz instruments company | SPOT RETINOSCOPE RX-3SP | March 28, 1995 |
| K950795 | neitz instruments company | STREAK RETINOSCOPE RX-RP | March 28, 1995 |
| K840840 | electro optical instruments | GENERATED RETINAL REFLEX IMAGERY SYS | July 12, 1984 |