510(k) K925638
K925638 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600". The FDA issued a decision of Substantially Equivalent on Oct 18, 1993. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 1993
- Date Received
- Nov 9, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transducer, Pressure, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.2870
- Review Panel
- CV
- Submission Type
- 510(k)