510(k) K191239
K191239 is an FDA 510(k) premarket notification submitted by Guangzhou Homesun Medical Technology Co., Ltd. for the device "Smart Peak Flow Meter". The FDA issued a decision of Substantially Equivalent on December 6, 2019. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Guangzhou Homesun Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2019
- Date Received
- May 8, 2019
- 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