510(k) clearances

AirKEE P900

Healkee Medical Pte, Ltd. · General Hospital

K232933Substantially EquivalentTraditionalFRA
Open FDA's page for this record
Third party flag
N
City
Singapore
Advisory committee description
General Hospital
Address 1
11 N. Buona Vista Dr.
Address 2
Level 08-09, The Metropolis Towel 2
Statement or summary
Summary
Product code
FRA
Zip code
138589
Applicant
Healkee Medical Pte, Ltd.
Decision date
2024-05-16
Decision code
SESE
Country code
SG
Device name
AirKEE P900
Advisory committee
HO
Contact
William Tao
K number
K232933
Date received
2023-09-20
Review advisory committee
HO
Postal code
138589
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Purifier, Air, Ultraviolet, Medical
Medical specialty description
General Hospital
Regulation number
880.6500
Device class
2
Registration number
3003547411, 3015376465, 3044735899, 3009522781, 3015139810, 3027534461, 3010446656, 3008156690, 3030650766, 3014151865, 3019585201, 3032191707, 3014498814
FEI number
3003547411, 3015376465, 3044735899, 3009522781, 3015139810, 3027534461, 3010446656, 3008156690, 3030650766, 3014151865, 3019585201, 3032191707, 3014498814
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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.