HME — Chair, Ophthalmic, Ac-Powered Class I
FDA Device Classification
Classification Details
- Product Code
- HME
- Device Class
- Class I
- Regulation Number
- 886.1140
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K930449 | marco ophthalmic | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | July 6, 1993 |
| K914416 | icor | BREATH-EASY, MODIFICATION | June 23, 1992 |
| K894018 | reliance medical products | RELIANCE(R) 6200 EXAMINATION CHAIR | September 12, 1989 |
| K870112 | storz instrument | STORZ ENT/OPHTHALMIC MAXI CHAIR | February 12, 1987 |
| K864494 | koken mfg company | MODEL 6500 OPTHALMIC CHAIR | December 15, 1986 |
| K864574 | koken mfg company | MAC 150E OPTHALMIC CHAIR | December 15, 1986 |
| K863728 | charles d. bell | THE ERGOSYSTEM CHAIR | October 31, 1986 |
| K863008 | sds dental | -OM WEST 2000 GNATUS CHAIR | September 24, 1986 |
| K853743 | techna vision | TECHNA VISION, INC. ELECTRIC CHAIR | October 17, 1985 |
| K853149 | f. and f. koenigkramer | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | September 5, 1985 |
| K853151 | f. and f. koenigkramer | RELIANCE 5000 | September 5, 1985 |
| K853150 | f. and f. koenigkramer | RELIANCE 6100 | September 5, 1985 |
| K842045 | woodlyn | WOODLYN CLASSIC EXAM. CHAIR | June 19, 1984 |
| K833539 | vision health technology | DOWING OPHTHALMIC CHAIR AC-POWERED | March 5, 1984 |
| K801638 | american optical | A O CUSTOM II CHAIR AND STAND | August 13, 1980 |
| K781801 | surgical mechanical research | MAXI-CHAIR | November 3, 1978 |