Sentry WEB SmartInterp
FDA 510(k) clearance K153654 · decided 2016-09-16
Clearance details
- K-number
- K153654
- Device name
- Sentry WEB SmartInterp
- Applicant
- Carefusion Germany 234 GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-12-21
- Decision date
- 2016-09-16
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hoechber, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.