The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Digital Infrared Forehead Thermometer, Model Fr1dm1.
Device ID | K033820 |
510k Number | K033820 |
Device Name: | MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 |
Classification | Thermometer, Electronic, Clinical |
Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-09 |
Decision Date | 2004-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00328785000627 | K033820 | 000 |
00328785000412 | K033820 | 000 |
10328785004899 | K033820 | 000 |