The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Temp Marq Temperature Trend Indicator.
Device ID | K903307 |
510k Number | K903307 |
Device Name: | TEMP MARQ TEMPERATURE TREND INDICATOR |
Classification | Strip, Temperature, Forehead, Liquid Crystal |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Contact | Warren L Bisbee |
Correspondent | Warren L Bisbee MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Product Code | KPD |
CFR Regulation Number | 880.2200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-24 |
Decision Date | 1990-08-17 |