The following data is part of a premarket notification filed by Liquid Crystal Products, Inc. with the FDA for Monitemp Blood Pack Temp. Monitor.
Device ID | K800667 |
510k Number | K800667 |
Device Name: | MONITEMP BLOOD PACK TEMP. MONITOR |
Classification | Refrigerator, Freezer, Blood Storage |
Applicant | LIQUID CRYSTAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KSE |
CFR Regulation Number | 864.9700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-26 |
Decision Date | 1980-04-16 |