The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Electronic Peak Flow Monitor, Model Pf-100.
| Device ID | K031024 |
| 510k Number | K031024 |
| Device Name: | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-11-14 |
| Summary: | summary |