GIVEN DIAGNOSTIC SYSTEM
FDA 510(k) clearance K031033 · decided 2003-07-01
Clearance details
- K-number
- K031033
- Device name
- GIVEN DIAGNOSTIC SYSTEM
- Applicant
- Given Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-07-01
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NEZ
- Device class
- 2
- Regulation number
- 876.1300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yoqneaam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.