PORTABLE ENDOSCOPY SYSTEM
FDA 510(k) clearance K950712 · decided 1996-05-14
Clearance details
- K-number
- K950712
- Device name
- PORTABLE ENDOSCOPY SYSTEM
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 1995-02-14
- Decision date
- 1996-05-14
- Days to decision
- 455 days
- Clearance type
- Traditional
- Product code
- GCM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mainz, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.