The following data is part of a premarket notification filed by Entracare Corp. with the FDA for Entracare Thermomter Model 1000.
| Device ID | K964851 |
| 510k Number | K964851 |
| Device Name: | ENTRACARE THERMOMTER MODEL 1000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ENTRACARE CORP. 14400 COLLEGE BLVD., SUITE 101 Lenexa, KS 66215 |
| Contact | Al Boedeker |
| Correspondent | Al Boedeker ENTRACARE CORP. 14400 COLLEGE BLVD., SUITE 101 Lenexa, KS 66215 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-02-03 |
| Summary: | summary |