The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Amer. 400 Series Temp. Probes-rectall.
| Device ID | K830839 |
| 510k Number | K830839 |
| Device Name: | AMER. 400 SERIES TEMP. PROBES-RECTALL |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 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 | 1983-03-16 |
| Decision Date | 1983-04-06 |