The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Endocare Electornic Thermometer System.
| Device ID | K961365 |
| 510k Number | K961365 |
| Device Name: | ENDOCARE ELECTORNIC THERMOMETER SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ENDOCARE, INC. 18 TECHNOLOGY DR., SUITE 134 Irvine, CA 92718 |
| Contact | Paul Mikus |
| Correspondent | Paul Mikus ENDOCARE, INC. 18 TECHNOLOGY DR., SUITE 134 Irvine, CA 92718 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-08-15 |
| Summary: | summary |