510(k) clearances

SpiroSphere, SpiroSphereECG, CardioSphere

Eresearchtechnology GmbH · Anesthesiology

K223629Substantially EquivalentTraditionalBTY
Open FDA's page for this record
Third party flag
Y
City
Estenfeld
Advisory committee description
Anesthesiology
Address 1
Sieboldstrasse 3
Statement or summary
Summary
Product code
BTY
Zip code
97230
Applicant
Eresearchtechnology GmbH
Decision date
2024-05-28
Decision code
SESE
Country code
DE
Device name
SpiroSphere, SpiroSphereECG, CardioSphere
Advisory committee
AN
Contact
Kristin Feld
K number
K223629
Date received
2022-12-05
Review advisory committee
CV
Postal code
97230
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
3033959233, 2134715, 3008505660, 3010594620, 3016218294, 3030308442, 2183022, 8030673, 2433214, 1000154583, 1314417, 3008072932, 3002808458, 9614485, 3037873864, 9615102, 9680276, 8021084
FEI number
3010320336, 3033959233, 1000271197, 3008505660, 3010594620, 3016218294, 3030308442, 2183022, 2995, 2433214, 1000154583, 1314417, 3008072932, 3002808458, 3004213967, 3037873864, 3002673652, 3003007937
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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.