510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973922Substantially Equivalent

Archimed 4210 and 4220

Esaote North America, Inc, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973922 is the FDA 510(k) clearance record for ARCHIMED 4210 AND 4220, cleared for Biosound Esaote, Inc. on under FDA product code LOS. FDA records list 20 510(k) clearances for Esaote North America, Inc, from to . As of , FDA records show no recalls naming K973922.

Clearance record

Decision date
Received
(209 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Biosound Esaote, Inc. 8000 Castleway Dr., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code LOS

Trailing 12 months

FDA records hold no clearances under product code LOS in the trailing twelve months.

FDA records show no clearances under product code LOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260