The following data is part of a premarket notification filed by Broadwest Corp. with the FDA for Inox Thermometer Jar.
Device ID | K852301 |
510k Number | K852301 |
Device Name: | INOX THERMOMETER JAR |
Classification | Thermometer, Clinical Mercury |
Applicant | BROADWEST CORP. 260 WEST BROADWAY New York, NY 10013 |
Contact | Jack Donovan |
Correspondent | Jack Donovan BROADWEST CORP. 260 WEST BROADWAY New York, NY 10013 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-29 |
Decision Date | 1985-07-01 |