510(k) clearances

Loss of Pulse Detection

Fitbit · Cardiovascular

K242967Substantially EquivalentTraditionalSDY
Open FDA's page for this record
Third party flag
N
City
San Francisco
Advisory committee description
Cardiovascular
Address 1
215 Fremont St.
Statement or summary
Summary
Product code
SDY
Zip code
94105
Applicant
Fitbit
Decision date
2025-02-25
Decision code
SESE
Country code
US
Device name
Loss of Pulse Detection
Advisory committee
CV
Contact
Dinesh Puppala
K number
K242967
State
CA
Date received
2024-09-26
Review advisory committee
CV
Postal code
94105
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Loss Of Pulse Notification Software
Medical specialty description
Cardiovascular
Regulation number
870.2790
Device class
2
Registration number
3009253624
FEI number
3009253624
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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.