The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Model Tp Thermistor Probe.
| Device ID | K831528 |
| 510k Number | K831528 |
| Device Name: | MODEL TP THERMISTOR PROBE |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | SCIMED LIFE SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885074286147 | K831528 | 000 |