510(k) clearances

CPETWise Platform

Medibyt , Ltd. · Anesthesiology

K260242Substantially EquivalentTraditionalBTY
Open FDA's page for this record
Third party flag
Y
City
Yakum
Advisory committee description
Anesthesiology
Address 1
Greenwork
Statement or summary
Summary
Product code
BTY
Zip code
6097200
Applicant
Medibyt , Ltd.
Decision date
2026-08-20
Decision code
SESE
Country code
IL
Device name
CPETWise Platform
Advisory committee
AN
Contact
Or Inbar
K number
K260242
Date received
2026-01-26
Review advisory committee
AN
Postal code
6097200
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Calculator, Predicted Values, Pulmonary Function
Medical specialty description
Anesthesiology
Regulation number
868.1890
Device class
2
Registration number
3008505660, 1000154583, 2134715, 1314417, 8030673, 2183022, 3002808458, 8021084, 3033959233, 9614485, 3037873864, 9615102, 9680276, 3016218294, 3010594620, 3008072932, 2433214, 3030308442
FEI number
3008505660, 1000154583, 3002808458, 1314417, 2183022, 3003007937, 3033959233, 2433214, 3037873864, 3016218294, 2995, 3010320336, 1000271197, 3010594620, 3008072932, 3004213967, 3030308442, 3002673652
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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.