510(k) K831528
K831528 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "MODEL TP THERMISTOR PROBE". The FDA issued a decision of Substantially Equivalent on Jun 30, 1983. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 1983
- Date Received
- May 12, 1983
- 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
- 510(k)