Cleared Traditional

ARCHIMED 4210 AND 4220 (K973922) - FDA 510(k) Clearance

K973922 · Biosound Esaote, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
209d
Days
-
Risk

K973922 is an FDA 510(k) clearance for the ARCHIMED 4210 AND 4220.

Submitted by Biosound Esaote, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 209 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 Biosound Esaote, Inc. devices

Submission Details

510(k) Number K973922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date May 12, 1998
Days to Decision 209 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
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