Atlas FDA

CARESCAPE MONITOR B650

FDA 510(k) clearance K102239 · decided 2010-10-18

Clearance details

K-number
K102239
Device name
CARESCAPE MONITOR B650
Applicant
GE Healthcare Finland Oy
Decision
Substantially Equivalent
Date received
2010-08-09
Decision date
2010-10-18
Days to decision
70 days
Clearance type
Traditional
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Helsinki, FI
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). recall (Z-1606-2015)GE Healthcare2015-05-12
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use recall (Z-2114-2014)GE Healthcare, LLC2014-07-24
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor recall (Z-1175-2014)GE Healthcare, LLC2014-03-11
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B65 recall (Z-0854-2014)GE Healthcare, LLC2014-01-28
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter pat recall (Z-2256-2013)GE Healthcare, LLC2013-09-19
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter pat recall (Z-0823-2013)GE Healthcare, LLC2013-02-14
GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter pati recall (Z-1930-2011)GE Healthcare, LLC2011-04-08