FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

THE VIRTUAL M-332

K Number: K960500 · Decision Apr 3, 1996
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
13
Applicant Total
9
Review Days
61

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Basic Information

Device Name
THE VIRTUAL M-332
K Number
K960500
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Virtual Corp.
Date Received
February 2, 1996
Decision Date
April 3, 1996
Product Code
EWD
Advisory Committee
Unknown
Review Advisory Committee
EN
Third Party
N

Classifications

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

Product Code Device Name
EWD Protector, Hearing (Insert)

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Other Clearances by Virtual Corp.

K Number Device Name
K934715 MODEL 222 CLINICAL AUDIOMETER
K930203 MODEL 322 CLINICAL AUDIOMETER
K926574 MODEL 330 SCREENING AUDIO METER, MODIFIED
K911689 MODEL 330 SCREENING AUDIOMETER
K895443 MODEL 210 IMPEDANCE SYSTEM
K896301 MODEL 340 PROBE MIC SYSTEM
K863984 MODEL 320 TWO CHANNEL AUDIOMETER
K853863 MODEL 310 IMPEDANCE SYSTEM