Cleared Traditional

K863204 - DEKA JR.
(FDA 510(k) Clearance)

K863204 · Deka Research & Development Corp. · General Hospital

Sep 1986

Decision

15d

Days

Class 2

Risk

K863204 is an FDA 510(k) clearance for the DEKA JR.. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR).

Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on September 3, 1986, 15 days after receiving the submission on August 19, 1986.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K863204 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1986
Decision Date	September 03, 1986
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—