Accuryn Monitoring System
FDA 510(k) clearance K153655 · decided 2016-04-15
Clearance details
- K-number
- K153655
- Device name
- Accuryn Monitoring System
- Applicant
- Potrero Medical, Inc.
- Decision
- Unknown
- Date received
- 2015-12-21
- Decision date
- 2016-04-15
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.