510(k) K222443
K222443 is an FDA 510(k) premarket notification submitted by Feellife Health, Inc. for the device "Air Smart Extra Spirometer". The FDA issued a decision of Substantially Equivalent on August 9, 2023. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Feellife Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2023
- Date Received
- August 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type