Panels › Ophthalmic › Product code HME · Class 1
Chair, Ophthalmic, Ac-Powered
Regulation 886.1140
0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HME
| Company | 510(k)s | Recalls |
|---|---|---|
| F. & F. Koenigkramer | 3 | 0 |
| Koken Mfg Company, Inc. | 2 | 0 |
| American Optical Corp. | 1 | 0 |
| Charles D. Bell, Inc. | 1 | 0 |
| Icor AB | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| Reliance Medical Products, Inc. | 1 | 0 |
| Sds Dental, Inc. | 1 | 0 |
| Storz Instrument Co. | 1 | 0 |
| Surgical Mechanical Research, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1993 | K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR Marco Ophthalmic, Inc. | HME |
| Jun 23, 1992 | K914416 | BREATH-EASY, MODIFICATION Icor AB, SE | HME |
| Sep 12, 1989 | K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR Reliance Medical Products, Inc. | HME |
| Feb 12, 1987 | K870112 | STORZ ENT/OPHTHALMIC MAXI CHAIR Storz Instrument Co. | HME |
| Dec 15, 1986 | K864574 | MAC 150E OPTHALMIC CHAIR Koken Mfg Company, Inc. | HME |
| Dec 15, 1986 | K864494 | MODEL 6500 OPTHALMIC CHAIR Koken Mfg Company, Inc. | HME |
| Oct 31, 1986 | K863728 | THE ERGOSYSTEM CHAIR Charles D. Bell, Inc. | HME |
| Sep 24, 1986 | K863008 | -OM WEST 2000 GNATUS CHAIR Sds Dental, Inc. | HME |
| Oct 17, 1985 | K853743 | TECHNA VISION, INC. ELECTRIC CHAIR Techna Vision | HME |
| Sep 5, 1985 | K853151 | RELIANCE 5000 F. & F. Koenigkramer | HME |
| Sep 5, 1985 | K853150 | RELIANCE 6100 F. & F. Koenigkramer | HME |
| Sep 5, 1985 | K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 F. & F. Koenigkramer | HME |
| Jun 19, 1984 | K842045 | WOODLYN CLASSIC EXAM. CHAIR Woodlyn, Inc. | HME |
| Mar 5, 1984 | K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED Vision Health Technology | HME |
| Aug 13, 1980 | K801638 | A O CUSTOM II CHAIR AND STAND American Optical Corp. | HME |
| Nov 3, 1978 | K781801 | MAXI-CHAIR Surgical Mechanical Research, Inc. | HME |
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