The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Klear-temp.
Device ID | K926030 |
510k Number | K926030 |
Device Name: | KLEAR-TEMP |
Classification | Warmer, Infant Radiant |
Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
Contact | Edward W Jackson |
Correspondent | Edward W Jackson CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
Product Code | FMT |
CFR Regulation Number | 880.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1994-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KLEAR-TEMP 74299032 1879159 Dead/Cancelled |
CAS Medical Systems, Inc. 1992-07-29 |