The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Electronic Peak Flow Monitor, With Pef And Fev1, Models Pf-100 And Pf-100-1 (with Software).
| Device ID | K040723 |
| 510k Number | K040723 |
| Device Name: | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) |
| Classification | Meter, Peak Flow, Spirometry |
| 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 | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-06-10 |
| Summary: | summary |