Cleared Traditional

K894093 - SPACELABS MODEL 90900 (FDA 510(k) Clearance)

K894093 · Spacelabs, Inc. · Cardiovascular device
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Nov 1989
Decision
174d
Days
-
Risk

K894093 is an FDA 510(k) clearance for the SPACELABS MODEL 90900.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 174 days - an extended review cycle.

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. Standard predicate reliance. 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 Spacelabs, Inc. devices

Submission Details

510(k) Number K894093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date November 30, 1989
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -