The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Modification To: Microlife Digital Pacifier Thermometer, Model Mt1751q.
| Device ID | K051100 |
| 510k Number | K051100 |
| Device Name: | MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q |
| 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 | 2005-04-29 |
| Decision Date | 2005-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00328785000436 | K051100 | 000 |