Atlas FDA

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE

FDA 510(k) clearance K071073 · decided 2007-05-11

Clearance details

K-number
K071073
Device name
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
Applicant
Ge Medical Systems Information Technologies
Decision
Substantially Equivalent
Date received
2007-04-16
Decision date
2007-05-11
Days to decision
25 days
Clearance type
Special
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CARESCAPE PDM-Masimo SpO2. Physiological data monitor. recall (Z-2139-2021)GE Healthcare, LLC2021-07-23
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/ recall (Z-2424-2020)GE Healthcare, LLC2020-06-24
GE Healthcare Carescape Patient Data Module recall (Z-0060-2015)GE Healthcare, LLC2014-10-09
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5. recall (Z-1147-2014)GE Healthcare, LLC2014-03-06
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Numb recall (Z-1095-2014)Cardiovascular Systems, Inc.2014-02-26
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-0807-2014)GE Healthcare, LLC2014-01-22
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to p recall (Z-0747-2014)GE Healthcare, LLC2014-01-14
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-0648-2014)GE Healthcare, LLC2014-01-09
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-2116-2013)GE Healthcare, LLC2013-08-28
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Tr recall (Z-0524-2013)GE Healthcare, LLC2012-12-14
GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module. recall (Z-0363-2011)GE Healthcare, LLC2010-11-15

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002)Ge Medical Systems Information Technologies2003-10-15
COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001)Ge Medical Systems Information Technologies2001-11-09
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016)Ge Medical Systems Information Technologies2001-02-09
MODEL 515 NEONATAL MONIOTR (P840037/S001)Ge Medical Systems Information Technologies1986-11-19