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

BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER

K Number: K854466 · Decision Feb 4, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
8
Review Days
90

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Basic Information

Device Name
BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
K Number
K854466
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1400
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Biomagnetic Technologies, Inc.
Date Received
November 6, 1985
Decision Date
February 4, 1986
Product Code
OLY
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
OLY Magnetoencephalograph

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K Number Device Name
K993708 BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K962317 MAGNES 2500 WH BIOMAGNETOMETER
K941553 MAGNES II BIOMAGNETOMETER
K921821 IBT MODEL SVI
K913604 SOMATOSENSORY STIMULUS SYSTEM
K901215 700 SERIES BIOMAGNETOMETER
K790031 GENERATOR, BIOTEC 876 PULSE