The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Temperature Module, Dual.
Device ID | K781136 |
510k Number | K781136 |
Device Name: | TEMPERATURE MODULE, DUAL |
Classification | Thermometer, Electronic, Clinical |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-07 |
Decision Date | 1978-08-10 |