TEMPTREND II
Strip, Temperature, Forehead, Liquid Crystal
BIOSYNERGY, INC.
The following data is part of a premarket notification filed by Biosynergy, Inc. with the FDA for Temptrend Ii.
Pre-market Notification Details
| Device ID | K833904 |
| 510k Number | K833904 |
| Device Name: | TEMPTREND II |
| Classification | Strip, Temperature, Forehead, Liquid Crystal |
| Applicant | BIOSYNERGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPD |
| CFR Regulation Number | 880.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1983-12-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
| M74411001 |
K833904 |
000 |
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