BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)— 510(k) K950897

Name: FDA 510(k) clearance K950897
Creator: U.S. Food and Drug Administration
Published: 1995-08-24

Substantially Equivalent

Biosystems

FDA 510(k) clearance K950897 for BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE), Substantially Equivalent on 1995-08-24. Applicant: Biosystems. Device class: 2.

Clearance details

Applicant: Biosystems
Product code: Code MMK
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 1995-02-27
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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