510(k) clearances

Airmod

Heroic Faith International , Ltd. · Anesthesiology

K242798Substantially EquivalentTraditionalBZQ
Open FDA's page for this record
Third party flag
N
City
Taipei
Advisory committee description
Anesthesiology
Address 1
18f., # 460, Sec. 4, Xinyi Rd., Xinyi Dist.
Statement or summary
Summary
Product code
BZQ
Zip code
110
Applicant
Heroic Faith International , Ltd.
Decision date
2025-02-28
Decision code
SESE
Country code
TW
Device name
Airmod
Advisory committee
AN
Contact
Cheng Yuan-ren
K number
K242798
Date received
2024-09-16
Review advisory committee
AN
Postal code
110
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Monitor, Breathing Frequency
Medical specialty description
Anesthesiology
Regulation number
868.2375
Device class
2
Registration number
3003263092, 3018094310, 3015282442, 3008729547, 1223925, 9611031, 1824206, 2029015, 3009499478, 3020018, 1314417, 3044754336, 3010390468, 3016674095, 3014541700, 3006157842, 9612330, 3016618143, 3012359877, 3013572357, 3013896610, 3013679558, 1066427, 1320894, 3026751377, 3004091281, 3027256461, 9610816, 2132556, 2025816, 3003971136, 3006125362, 3004415095, 3023146633, 3008483389, 3028169073, 3015529350, 3038761440, 3030733800, 8020893 +73 more
FEI number
3003263092, 3018094310, 3015282442, 3008729547, 1000160458, 1824206, 3009499478, 3020018, 1314417, 3044754336, 3010390468, 3016674095, 3014541700, 3006157842, 3016618143, 3012359877, 3013572357, 3013896610, 3013679558, 3003076831, 3026751377, 3027256461, 2025816, 3003971136, 3006254866, 3006125362, 3000215024, 6736, 3004415095, 3023146633, 3008483389, 3028169073, 3015529350, 3038761440, 3030733800, 3007513035, 3002809369, 3007305624, 3000126629, 3012933969 +73 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.