The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp(r) Myocardial Temperature Sensor.
| Device ID | K874605 |
| 510k Number | K874605 |
| Device Name: | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
| Contact | Philip E Wiegert |
| Correspondent | Philip E Wiegert MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-02-02 |