BREATH-EASY, MODIFICATION
FDA 510(k) clearance K914416 · decided 1992-06-23
Clearance details
- K-number
- K914416
- Device name
- BREATH-EASY, MODIFICATION
- Applicant
- Icor AB
- Decision
- Substantially Equivalent
- Date received
- 1991-09-25
- Decision date
- 1992-06-23
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- HME
- Device class
- 1
- Regulation number
- 886.1140
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bromma, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (K930449) | Marco Ophthalmic, Inc. | 1993-07-06 |
| RELIANCE(R) 6200 EXAMINATION CHAIR (K894018) | Reliance Medical Products, Inc. | 1989-09-12 |
| STORZ ENT/OPHTHALMIC MAXI CHAIR (K870112) | Storz Instrument Co. | 1987-02-12 |
| MODEL 6500 OPTHALMIC CHAIR (K864494) | Koken Mfg Company, Inc. | 1986-12-15 |
| MAC 150E OPTHALMIC CHAIR (K864574) | Koken Mfg Company, Inc. | 1986-12-15 |
| THE ERGOSYSTEM CHAIR (K863728) | Charles D. Bell, Inc. | 1986-10-31 |
| -OM WEST 2000 GNATUS CHAIR (K863008) | Sds Dental, Inc. | 1986-09-24 |
| TECHNA VISION, INC. ELECTRIC CHAIR (K853743) | Techna Vision | 1985-10-17 |
| RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (K853149) | F. & F. Koenigkramer | 1985-09-05 |
| RELIANCE 6100 (K853150) | F. & F. Koenigkramer | 1985-09-05 |
| RELIANCE 5000 (K853151) | F. & F. Koenigkramer | 1985-09-05 |
| WOODLYN CLASSIC EXAM. CHAIR (K842045) | Woodlyn, Inc. | 1984-06-19 |
Recalls involving this device
No recalls on record reference this clearance.