The following data is part of a premarket notification filed by Science Development Corp. with the FDA for Scd Skin Temp. Sensors #3400 Etc.
Device ID | K832090 |
510k Number | K832090 |
Device Name: | SCD SKIN TEMP. SENSORS #3400 ETC |
Classification | Thermometer, Electronic, Clinical |
Applicant | SCIENCE DEVELOPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-28 |
Decision Date | 1983-10-31 |