The following data is part of a premarket notification filed by Breathe Me Ltd with the FDA for Peak.me.
| Device ID | K180487 |
| 510k Number | K180487 |
| Device Name: | Peak.me |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Breathe Me LTD 13 Zarchin Street Ra'anana, IL 4366241 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 30500 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-23 |
| Decision Date | 2018-10-26 |
| Summary: | summary |