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

BNS 40

K Number: K842224 · Decision Nov 19, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
8
Review Days
167

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Basic Information

Device Name
BNS 40
K Number
K842224
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5850
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Myo-Tronics Research, Inc.
Date Received
June 5, 1984
Decision Date
November 19, 1984
Product Code
NUW
Advisory Committee
Physical Medicine
Review Advisory Committee
DE
Third Party
N

Classifications

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

Product Code Device Name
NUW Stimulator, Muscle, Powered, Dental

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Other Clearances by Myo-Tronics Research, Inc.

K Number Device Name
K842223 J4 MYO-MONITOR
K833132 MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
K831364 TESTCORP RA
K830034 MODEL EM-2 BIOELECTRIC PROCESSOR
K813533 ELECTRIC MUSCLE STIMULATOR
K810528 MODEL EM-IR
K770252 MONITOR, MYO, MODEL J3