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

DISPOSABLE PATIENT CABLE

K Number: K910645 · Decision May 7, 1991
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
9
Review Days
83

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Basic Information

Device Name
DISPOSABLE PATIENT CABLE
K Number
K910645
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2900
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Diag Corp.
Date Received
February 13, 1991
Decision Date
May 7, 1991
Product Code
DSA
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
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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K812270 PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL
K800349 ENDOCARD. PACING LEAD LONG LENGTH PL200