FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

K Number: K040228 · Decision Apr 29, 2004
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
2
Review Days
87

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Basic Information

Device Name
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
K Number
K040228
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2100
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Medi-Stim A/S
Date Received
February 2, 2004
Decision Date
April 29, 2004
Product Code
DPW
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
DPW Flowmeter, Blood, Cardiovascular

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Other Clearances by Medi-Stim A/S

K Number Device Name
K992305 MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004