510(k) K101189
K101189 is an FDA 510(k) premarket notification submitted by Reavillmed for the device "REAVILLMED PRESSURE MONITORING SYSTEM AND PICC". The FDA issued a decision of Substantially Equivalent on December 22, 2010. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2010
- Date Received
- April 28, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type