The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Myocardial Temperature Monitoring Probes, Cj-1000.
Device ID | K905652 |
510k Number | K905652 |
Device Name: | MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000 |
Classification | Thermometer, Electronic, Clinical |
Applicant | DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
Contact | Alan Seacord |
Correspondent | Alan Seacord DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-18 |
Decision Date | 1991-02-14 |