eQUANT System— 510(k) K231536

Substantially Equivalent

Avails Medical, Inc.

FDA 510(k) clearance K231536 for eQUANT System, Substantially Equivalent on 2024-02-08. Applicant: Avails Medical, Inc.. Device class: 2.

Clearance details

Applicant
Avails Medical, Inc.
Product code
Code QZX
Device class
Class 2
Regulation
21 CFR 866.1650
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Menlo Park, CA, US
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