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 Mt18l1.
Device ID | K043110 |
510k Number | K043110 |
Device Name: | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 |
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 | 2004-11-10 |
Decision Date | 2004-12-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00328785000481 | K043110 | 000 |
10328785000273 | K043110 | 000 |
00328785000115 | K043110 | 000 |
00328785000061 | K043110 | 000 |
00634782588335 | K043110 | 000 |
B268B111859 | K043110 | 000 |