Atlas FDA

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

FDA 510(k) clearance K080461 · decided 2008-03-13

Clearance details

K-number
K080461
Device name
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
Applicant
Philips Medical Systems
Decision
Substantially Equivalent
Date received
2008-02-20
Decision date
2008-03-13
Days to decision
22 days
Clearance type
Special
Product code
MLD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Andover, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017)Philips Medical Systems2025-09-05
HeartStart FRx Defibrillator (861304) (P180028/S016)Philips Medical Systems2025-06-09
HeartStart FRx Defibrillator (P180028/S015)Philips Medical Systems2025-05-09
HeartStart FRx Defibrillator (861304) (P180028/S014)Philips Medical Systems2024-02-21
HeartStart FRx Defibrillator (P180028/S013)Philips Medical Systems2023-04-03
HeartStart FRx Defibrillator (P180028/S012)Philips Medical Systems2022-03-20
HeartStart FRx Defibrillator (861304) (P180028/S011)Philips Medical Systems2021-11-15
HeartStart FRx Defibrillator (861304) (P180028/S010)Philips Medical Systems2021-09-24