The following data is part of a premarket notification filed by Science Regulatory Services Intl. with the FDA for Diotherm.
| Device ID | K895137 |
| 510k Number | K895137 |
| Device Name: | DIOTHERM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW Washington, DC 20006 |
| Contact | Michael Farrow |
| Correspondent | Michael Farrow SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW Washington, DC 20006 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-16 |
| Decision Date | 1990-11-16 |