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 |