FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

LIDCORAPID V2 MONITOR

K Number: K122247 · Decision Mar 20, 2013
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
7
Review Days
236

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Basic Information

Device Name
LIDCORAPID V2 MONITOR
K Number
K122247
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1435
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Lidco, Ltd.
Date Received
July 27, 2012
Decision Date
March 20, 2013
Product Code
DXG
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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K010049 PULSECO HEMODYNAMIC MONITOR CM71
K962918 LIDCO SYSTEM