510(k) K942377
K942377 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "TRANSTAR PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on August 16, 1994. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Medex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1994
- Date Received
- May 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type