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

CMT-1000

K Number: K942428 · Decision May 23, 1995
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
2
Review Days
368

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Basic Information

Device Name
CMT-1000
K Number
K942428
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Ems, Inc.
Date Received
May 20, 1994
Decision Date
May 23, 1995
Product Code
LIH
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

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

Product Code Device Name
LIH Interferential Current Therapy

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K Number Device Name
K946018 TENS-IT, FITTRONIC II, (MORE LATER)