TEMPERATURE SENSOR CATHETER
FDA 510(k) clearance K131020 · decided 2013-05-09
Clearance details
- K-number
- K131020
- Device name
- TEMPERATURE SENSOR CATHETER
- Applicant
- Degania Silicone , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-12
- Decision date
- 2013-05-09
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Israel, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.