The following data is part of a premarket notification filed by Franklin Diagnostics, Inc. with the FDA for Franklin Collector(r).
Device ID | K884612 |
510k Number | K884612 |
Device Name: | FRANKLIN COLLECTOR(R) |
Classification | Thermometer, Clinical Color Change |
Applicant | FRANKLIN DIAGNOSTICS, INC. 60 FRANKLIN ST. Morristown, NJ 07960 |
Contact | L Ehrenkranz |
Correspondent | L Ehrenkranz FRANKLIN DIAGNOSTICS, INC. 60 FRANKLIN ST. Morristown, NJ 07960 |
Product Code | FQZ |
CFR Regulation Number | 880.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-04 |
Decision Date | 1989-03-27 |