The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Heart Rate & Temp. Measurement System.
Device ID | K822939 |
510k Number | K822939 |
Device Name: | HEART RATE & TEMP. MEASUREMENT SYSTEM |
Classification | Thermometer, Electronic, Clinical |
Applicant | CAMINO LABORATORIES, INC. CA |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-04 |
Decision Date | 1982-11-24 |