510(k) K180487
K180487 is an FDA 510(k) premarket notification submitted by Breathe Me, Ltd. for the device "Peak.me". The FDA issued a decision of Substantially Equivalent on October 26, 2018. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2018
- Date Received
- February 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type