Product Code: OSZ FDA class 2 21 CFR 880.6600

Antimicrobial Keyboard

General Hospital

The Antimicrobial Keyboard (product code OSZ) is a hospital-grade keyboard designed to reduce microbial populations on its surface through incorporated antimicrobial agents or materials. It is intended for use in healthcare settings where infection control is critical. As an FDA Class 2 device under regulation 880.6600, it requires 510(k) premarket clearance and falls within the General Hospital specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.

510(k)s
1
FEI Numbers
2
Registration Numbers
2
Unique Applicants
1
Years Active

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Basic Information

Product Code
OSZ
Device Class
FDA class 2
Regulation Number
880.6600
Medical Specialty
General Hospital
Review Panel
HO
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

To reduce microbial populations

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
DEN100013 VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50

FEI Numbers

This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.