The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Accutemp-probe.
Device ID | K970686 |
510k Number | K970686 |
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 | 1997-02-25 |
Decision Date | 1997-08-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCUTEMP-PROBE 74614018 not registered Dead/Abandoned |
Kentec Medical, Inc. 1994-12-20 |