510(k) K830909
K830909 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MIKRO-TIP CATH. PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on April 18, 1983. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1983
- Date Received
- March 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Thermodilution
- Device Class
- Class II
- Regulation Number
- 870.1915
- Review Panel
- CV
- Submission Type