The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Disposable Pharmaseal Temperature Monitoring Probe.
| Device ID | K864397 |
| 510k Number | K864397 |
| Device Name: | DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Lawrence Getlin |
| Correspondent | Lawrence Getlin AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-06 |
| Decision Date | 1986-12-01 |