510(k) K181666
K181666 is an FDA 510(k) premarket notification submitted by Mir Medical International Research for the device "Smart One". The FDA issued a decision of Substantially Equivalent on August 1, 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
- August 1, 2018
- Date Received
- June 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type