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

DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101

K Number: K922009 · Decision Feb 25, 1993
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
19
Review Days
302

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Basic Information

Device Name
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K Number
K922009
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2900
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Remington Medical, Inc.
Date Received
April 29, 1992
Decision Date
February 25, 1993
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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K251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
K241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
K211589 VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
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