Cleared Traditional

K901986 - CO-OXIMETER CONTROLS
(FDA 510(k) Clearance)

K901986 · Phoenix Diagnostics, Inc. · Chemistry

May 1990

Decision

29d

Days

Class 1

Risk

K901986 is an FDA 510(k) clearance for the CO-OXIMETER CONTROLS, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on May 31, 1990, 29 days after receiving the submission on May 2, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K901986 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1990
Decision Date	May 31, 1990
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—