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

NEUROMATIC 2000

K Number: K821237 · Decision May 21, 1982
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
2
Review Days
23

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Basic Information

Device Name
NEUROMATIC 2000
K Number
K821237
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.1375
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Disa Electronics
Date Received
April 28, 1982
Decision Date
May 21, 1982
Product Code
IKN
Advisory Committee
Physical Medicine
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
IKN Electromyograph, Diagnostic

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K Number Device Name
K820144 DISA WATER CYSTOMETER