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

NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8

K Number: K001692 · Decision Nov 24, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
4
Review Days
175

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Basic Information

Device Name
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K Number
K001692
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1550
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Neurosoft, Inc.
Date Received
June 2, 2000
Decision Date
November 24, 2000
Product Code
JXE
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
JXE Device, Nerve Conduction Velocity Measurement

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (JXE), ordered by most recent decision date.

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Other Clearances by Neurosoft, Inc.

K Number Device Name
K011241 NEUROSOFT'S SOURCE
K001781 CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K000812 NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)