Cleared Traditional

K894093 - SPACELABS MODEL 90900

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

FDA 510(k) Submission Details - K894093

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 44
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