The following data is part of a premarket notification filed by 3t Medical Systems, Llc. with the FDA for 3tm Myocardial Needle-temperature Probe.
| Device ID | K020365 |
| 510k Number | K020365 |
| Device Name: | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Contact | Robert P Eaton |
| Correspondent | Robert P Eaton 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817278012587 | K020365 | 000 |
| 10817278011402 | K020365 | 000 |
| 10817278010177 | K020365 | 000 |
| 10817278010160 | K020365 | 000 |
| 10817278010153 | K020365 | 000 |
| 20817499020198 | K020365 | 000 |
| 20817499020181 | K020365 | 000 |