The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp(r) Model 8700 Patient Temp Monitor.
Device ID | K874568 |
510k Number | K874568 |
Device Name: | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR |
Classification | Thermometer, Electronic, Clinical |
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 | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-05 |
Decision Date | 1988-01-06 |