SKYTRON EXAM LIGHT
FDA 510(k) clearance K933564 · decided 1994-02-10
Clearance details
- K-number
- K933564
- Device name
- SKYTRON EXAM LIGHT
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-22
- Decision date
- 1994-02-10
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- KZF
- Device class
- 1
- Regulation number
- 880.6320
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Grand Rapids, MI, US
- 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 |
|---|---|---|
| NEVOSCOPE (K954943) | Nizar A. Mullani | 1996-03-27 |
| WELCH ALLYN VIDEO EPISCOPE (K952835) | Welch Allyn, Inc. | 1995-09-22 |
| H 5100, H 5200, H 5300 (K945507) | Rudolf Riester GmbH & Co. KG | 1994-12-09 |
| SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (K941869) | The Lighthouse For the Blind, Inc. | 1994-08-03 |
| WAVE FLUORESCENT MAGNIFIER (K936088) | Burton Medical Products Corp. | 1994-04-26 |
| MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (K940284) | Meddev International Corp. | 1994-02-28 |
| CHROMOPHARE (K935832) | Berchtold Holding GmbH | 1994-02-03 |
| AC-POWERED MEDICAL EXAMINATION LIGHT (K934259) | Welch Allyn, Inc. | 1994-01-28 |
| RITTER MODEL 158 AND 159 EXAM LIGHTS (K932719) | Midmark Corp. | 1993-12-02 |
| VITAPEN (K924447) | Vitajet Corp. | 1993-09-27 |
| MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT (K931197) | Meddev International Corp. | 1993-09-23 |
| HALUX TASKLIGHT (K931645) | Burton Medical Products Corp. | 1993-08-20 |
Recalls involving this device
No recalls on record reference this clearance.