510(k) K812944
K812944 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1981
- Date Received
- October 20, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type