510(k) K112657
K112657 is an FDA 510(k) premarket notification submitted by Transonic Systems, Inc. for the device "AUREFLO MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2011. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Transonic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2011
- Date Received
- September 13, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type