510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974079Substantially Equivalent

Formula for Archimed

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

K974079 is the FDA 510(k) clearance record for FORMULA FOR ARCHIMED, a class II device, cleared for Biosound Esaote, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 20 510(k) clearances for Esaote North America, Inc, from to . As of , FDA records show no recalls naming K974079.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosound Esaote, Inc. 8000 Castleway Dr., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DPS

Trailing 12 months
5 clearances under product code DPS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260