Cleared Traditional

OXYCONALPHA WITH OPTION ECG

K984465 · Erich Jaeger B.V. · Cardiovascular

Oct 1999

Decision

315d

Days

—

Risk

About This 510(k) Submission

K984465 is an FDA 510(k) clearance for the OXYCONALPHA WITH OPTION ECG, submitted by Erich Jaeger B.V. (Nl-3981 La Bunnik, NL). The FDA issued a Cleared decision on October 27, 1999, 315 days after receiving the submission on December 16, 1998. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number	K984465 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1998
Decision Date	October 27, 1999
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement