rescuenet
FDA 510(k) clearance K152580 · decided 2015-11-03
Clearance details
- K-number
- K152580
- Device name
- rescuenet
- Applicant
- Endochoice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-10
- Decision date
- 2015-11-03
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.