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 |