INFRA VISION IMAGING SYSTEM
FDA 510(k) clearance K945297 · decided 1994-12-20
Clearance details
- K-number
- K945297
- Device name
- INFRA VISION IMAGING SYSTEM
- Applicant
- Gabriel Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-31
- Decision date
- 1994-12-20
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lafayette, LA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endo recall (Z-0906-2011) | Stryker Endoscopy | 2011-01-18 |