The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Reusable & Disposable Temp. Probes.
Device ID | K813459 |
510k Number | K813459 |
Device Name: | REUSABLE & DISPOSABLE TEMP. PROBES |
Classification | Thermometer, Electronic, Clinical |
Applicant | ELECTROMEDICS, INC. 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 | 1981-12-01 |
Decision Date | 1982-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B040XE24252W | K813459 | 000 |
B040XE21262U | K813459 | 000 |
B040XE21252T | K813459 | 000 |
B04024262T | K813459 | 000 |
B04024242R | K813459 | 000 |
B04024232Q | K813459 | 000 |
B04021242O | K813459 | 000 |
B04021232N | K813459 | 000 |