The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Accutemp Probe.
| Device ID | K960080 |
| 510k Number | K960080 |
| Device Name: | ACCUTEMP PROBE |
| Classification | Warmer, Infant Radiant |
| Applicant | KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Contact | Matt Wilken |
| Correspondent | Matt Wilken KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-05-01 |