The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Instant Digital Electronic Thermometer, Model Qt1jc1.
Device ID | K062867 |
510k Number | K062867 |
Device Name: | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-25 |
Decision Date | 2006-12-06 |
Summary: | summary |