Air Smart Extra Spirometer
FDA 510(k) clearance K222443 · decided 2023-08-09
Clearance details
- K-number
- K222443
- Device name
- Air Smart Extra Spirometer
- Applicant
- Feellife Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-12
- Decision date
- 2023-08-09
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- BZG
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.