The following data is part of a premarket notification filed by Science Development Corp. with the FDA for Sdc Rectal Temp. Probe Product #1020.
Device ID | K830039 |
510k Number | K830039 |
Device Name: | SDC RECTAL TEMP. PROBE PRODUCT #1020 |
Classification | Thermometer, Electronic, Clinical |
Applicant | SCIENCE DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-07 |
Decision Date | 1983-02-23 |