The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Digital Underarm Electronic Thermometer, Model Mt 18e1 (v932).
Device ID | K032364 |
510k Number | K032364 |
Device Name: | MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) |
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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-31 |
Decision Date | 2003-09-23 |
Summary: | summary |