Cleared Traditional

DAXOR MAX100 SYRINGE (MAX100)

K970419 · Daxor Corporation · General Hospital
Dec 1997
Decision
321d
Days
Class 2
Risk

About This 510(k) Submission

K970419 is an FDA 510(k) clearance for the DAXOR MAX100 SYRINGE (MAX100), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Daxor Corporation (Knoxville, US). The FDA issued a Cleared decision on December 22, 1997, 321 days after receiving the submission on February 4, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K970419 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1997
Decision Date December 22, 1997
Days to Decision 321 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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