510(k) K834040
K834040 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "MINATURE PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1984
- Date Received
- November 23, 1983
- 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