Cleared Traditional

K953363 - OXIFLOW DIGITAL RECORDER
(FDA 510(k) Clearance)

K953363 · Edentec Corp. · Anesthesiology

Feb 1996

Decision

204d

Days

Class 2

Risk

K953363 is an FDA 510(k) clearance for the OXIFLOW DIGITAL RECORDER, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on February 6, 1996, 204 days after receiving the submission on July 17, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K953363 FDA.gov
FDA Decision	Cleared ST
Date Received	July 17, 1995
Decision Date	February 06, 1996
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—