510(k) clearances

Etiometry Platform (DAV 5.4 RAE 9.2)

Etiometry, Inc. · Cardiovascular

K241479Substantially EquivalentTraditionalPPW
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Third party flag
N
City
Boston
Advisory committee description
Cardiovascular
Address 1
280 Summer St. Fourth Floor
Statement or summary
Summary
Product code
PPW
Zip code
02210
Applicant
Etiometry, Inc.
Decision date
2025-02-12
Decision code
SESE
Country code
US
Device name
Etiometry Platform (DAV 5.4 RAE 9.2)
Advisory committee
CV
Contact
Tim Hanson
K number
K241479
State
MA
Date received
2024-05-24
Review advisory committee
CV
Postal code
02210
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Adjunctive Cardiovascular Status Indicator
Medical specialty description
Cardiovascular
Regulation number
870.2200
Device class
2
Registration number
3030597723, 3011683100, 3008061490
FEI number
3030597723, 3011683100, 3008061490
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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.