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510(k) K973922

ARCHIMED 4210 AND 4220 by Biosound Esaote, Inc. — Product Code LOS

K973922 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "ARCHIMED 4210 AND 4220". The FDA issued a decision of Substantially Equivalent on May 12, 1998. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1998
Date Received
October 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Biosound Esaote, Inc.

  • K023255 — TECHNOS MP, MODEL AU6 (February 11, 2003)
  • K014168 — AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE (April 25, 2002)
  • K020164 — E-SCAN XQ (February 12, 2002)
  • K012728 — E-SCAN MRI SYSTEM (August 29, 2001)
  • K010405 — 7230 ULTRASOUND IMAGING SYSTEM WITH TEI (March 13, 2001)
  • K010057 — MODIFICATION TO ARTOSCAN M (February 2, 2001)
  • K001894 — MODIFICATION TO E-SCAN (July 6, 2000)
  • K000931 — AU5 ULTRASOUND IMAGING SYSTEM (June 8, 2000)
  • K000681 — AU5, AU6 (May 3, 2000)
  • K994369 — 7250 (MEGAS) (February 24, 2000)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)

FDA data resources