BWF

Spirometer, Therapeutic (Incentive)

Product code
BWF
Device name
Spirometer, Therapeutic (Incentive)
Device class
Class 2
21 CFR
21 CFR 868.5690
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
108 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-21.

NumberDecision dateApplicantDevice nameSummary
K2411522025-08-21Tidal Medical Technologies, LLCInSeePDF
K2338552024-02-02Enchant Tek Co. , Ltd.AllPEPPDF

2 summaries are archived here for direct download.

Official FDA classification page: BWF
Classification and pathway per current FDA publications. Data from openFDA (CC0).