DIGICELL 300 SYSTEM— 510(k) K873271

Name: FDA 510(k) clearance K873271
Creator: U.S. Food and Drug Administration
Published: 1987-11-06

Substantially Equivalent

Contraves Medical Instruments, Inc.

FDA 510(k) clearance K873271 for DIGICELL 300 SYSTEM, Substantially Equivalent on 1987-11-06. Applicant: Contraves Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Contraves Medical Instruments, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1987-08-17
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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