Atlas FDA

HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A

FDA 510(k) clearance K003819 · decided 2001-05-02

Clearance details

K-number
K003819
Device name
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
Applicant
Agilent Technologies, Inc.
Decision
Substantially Equivalent
Date received
2000-12-11
Decision date
2001-05-02
Days to decision
142 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Seattle, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configu recall (Z-0470-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; config recall (Z-0471-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text p recall (Z-0472-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text p recall (Z-0473-2011)Philips Medical Systems2010-11-26

PMA approvals by this applicant

RecordFirmDate
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
PD-L1 IHC 22C3 PHARMDX (P150013/S030)Agilent Technologies, Inc.2025-06-27
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002)Agilent Technologies, Inc.2025-02-28
PD-L1 IHC 22C3 pharmDx (P150013/S029)Agilent Technologies, Inc.2025-02-28
MAGE-A4 IHC 1F9 pharmDx (P230016/S001)Agilent Technologies, Inc.2025-02-28