The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Thermocouple Adapter.
Device ID | K873833 |
510k Number | K873833 |
Device Name: | THERMOCOUPLE ADAPTER |
Classification | Thermometer, Electronic, Clinical |
Applicant | MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
Contact | Wiegert, Phd |
Correspondent | Wiegert, Phd MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-21 |
Decision Date | 1987-11-03 |