Cleared Traditional

OXYCON PRO

K992214 · Erich Jaeger B.V. · Anesthesiology

Feb 2000

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K992214 is an FDA 510(k) clearance for the OXYCON PRO, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Erich Jaeger B.V. (Nl-3981 La Bunnik, NL). The FDA issued a Cleared decision on February 22, 2000, 236 days after receiving the submission on July 1, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number	K992214 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 1999
Decision Date	February 22, 2000
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement