Cleared Traditional

K973922 - ARCHIMED 4210 AND 4220

K973922 · Biosound Esaote, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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

FDA 510(k) Submission Details - K973922

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 65
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