Cleared Traditional

K984465 - OXYCONALPHA WITH OPTION ECG

K984465 · Erich Jaeger B.V. · Cardiovascular device
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Oct 1999
Decision
315d
Days
-
Risk

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 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Erich Jaeger B.V. devices

FDA 510(k) Submission Details - K984465

510(k) Number K984465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

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