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 |
| 00328785004656 | K043110 | 000 |
| 20328785004667 | K043110 | 000 |
| 00328785004694 | K043110 | 000 |
| 20328785006296 | K043110 | 000 |
| 00328785006308 | K043110 | 000 |
| 20328785006319 | K043110 | 000 |
| 20328785006326 | K043110 | 000 |
| 00328785012392 | K043110 | 000 |
| 50328785524654 | K043110 | 000 |
| B268B111859 | K043110 | 000 |
| 00634782588335 | K043110 | 000 |
| 00328785000061 | K043110 | 000 |
| 00328785000115 | K043110 | 000 |
| 10328785000273 | K043110 | 000 |
| 00328785002126 | K043110 | 000 |