FDA Product Code
FDA Product Code HME — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1140
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Marco Ophthalmic, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K914416 | BREATH-EASY, MODIFICATION | Icor AB | 1992-06-23 | Traditional | PDF ↗ |
| K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR | Reliance Medical Products, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K870112 | STORZ ENT/OPHTHALMIC MAXI CHAIR | Storz Instrument Co. | 1987-02-12 | Traditional | PDF ↗ |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K864574 | MAC 150E OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K863728 | THE ERGOSYSTEM CHAIR | Charles D. Bell, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sds Dental, Inc. | 1986-09-24 | Traditional | PDF ↗ |
| K853743 | TECHNA VISION, INC. ELECTRIC CHAIR | Techna Vision | 1985-10-17 | Traditional | PDF ↗ |
| K853151 | RELIANCE 5000 | F. & F. Koenigkramer | 1985-09-05 | Traditional | PDF ↗ |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | F. & F. Koenigkramer | 1985-09-05 | Traditional | PDF ↗ |
| K853150 | RELIANCE 6100 | F. & F. Koenigkramer | 1985-09-05 | Traditional | PDF ↗ |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Woodlyn, Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED | Vision Health Technology | 1984-03-05 | Traditional | PDF ↗ |
| K801638 | A O CUSTOM II CHAIR AND STAND | American Optical Corp. | 1980-08-13 | Traditional | PDF ↗ |
| K781801 | MAXI-CHAIR | Surgical Mechanical Research, Inc. | 1978-11-03 | Traditional | PDF ↗ |
Product code HME · Class I · Ophthalmic. Data: openFDA.