510(k) K133925
K133925 is an FDA 510(k) premarket notification submitted by Carefusion Germany 234 GmbH for the device "VYNTUS/ SENTRYSUITE PRODUCT LINE". The FDA issued a decision of Substantially Equivalent on August 22, 2014. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Carefusion Germany 234 GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2014
- Date Received
- December 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type