Cleared Traditional

KSEA MODEL 383320 20 ANGIOMAT

K960486 · Karl Storz Endoscopy · General Hospital
Oct 1996
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K960486 is an FDA 510(k) clearance for the KSEA MODEL 383320 20 ANGIOMAT, a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on October 25, 1996, 266 days after receiving the submission on February 2, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number K960486 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1996
Decision Date October 25, 1996
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DQI — Withdrawal/infusion Pump
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1800

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