FDA 510(k) Substantially Equivalent 🇺🇸 United States

FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH

K Number: K971440 · Decision Dec 2, 1997
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
68
Review Days
228

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Basic Information

Device Name
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K Number
K971440
Clearance Type
Traditional
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Fukuda Denshi USA, Inc.
Date Received
April 18, 1997
Decision Date
December 2, 1997
Product Code
LOS
Advisory Committee
Unknown
Review Advisory Committee
CV
Third Party
N

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