510(k) clearances

Body Temperature Software (BTS)

Fitbit, LLC · General Hospital

K243778Substantially EquivalentSpecialQZA
Open FDA's page for this record
Third party flag
N
City
San Francisco
Advisory committee description
General Hospital
Address 1
215 Fremont St.
Statement or summary
Summary
Product code
QZA
Zip code
94105
Applicant
Fitbit, LLC
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
Body Temperature Software (BTS)
Advisory committee
HO
Contact
Nathan Austin
K number
K243778
State
CA
Date received
2024-12-09
Review advisory committee
HO
Postal code
94105
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Body Temperature Sensing Software
Medical specialty description
General Hospital
Regulation number
880.2915
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.