Atlas FDA

HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B

FDA 510(k) clearance K010634 · decided 2001-06-11

Clearance details

K-number
K010634
Device name
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
Applicant
Agilent Technologies, Inc.
Decision
Substantially Equivalent
Date received
2001-03-02
Decision date
2001-06-11
Days to decision
101 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
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

RecordFirmDate
Philips HeartStart XL, Model M4735A Defibrillator/Monitor recall (Z-0343-03)Philips Medical Systems, Inc. Cardiac & Monitoring Systems2002-12-18

PMA approvals by this applicant

RecordFirmDate
PD-L1 IHC 28-8 pharmDx (P150025/S018)Agilent Technologies, Inc.2026-07-01
PD-L1 IHC 22C3 pharmDx (P150013/S031)Agilent Technologies, Inc.2026-03-19
PD-L1 IHC 22C3 pharmDx (P150013/S032)Agilent Technologies, Inc.2026-02-11
PD-L1 IHC 22C3 pharmDx (P150013/S033)Agilent Technologies, Inc.2026-02-10
MMR IHC Panel pharmDx (Dako Omnis) (P250004)Agilent Technologies, Inc.2025-08-15
PD-L1 IHC 22C3 pharmDx (Dako Omnis) (P150013/S028)Agilent Technologies, Inc.2025-08-04
PD-L1 IHC 28-8 pharmDx (P150025/S017)Agilent Technologies, Inc.2025-06-27
MAGE-A4 IHC 1F9 pharmDx (P230016/S002)Agilent Technologies, Inc.2025-06-27