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510(k) K904600

L582 TRANSDUCER by Acuson Corp. — Product Code MAA

K904600 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "L582 TRANSDUCER". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. Acuson Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
October 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Fetal Doppler Ultrasound
Device Class
Class II
Regulation Number
884.2660
Review Panel
RA
Submission Type

Other clearances by Acuson Corp.

  • K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (November 22, 2002)
  • K022896 — CSV12 SOFTWARE VIEWER (October 3, 2002)
  • K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM (August 13, 2002)
  • K021497 — CYPRESS ULTRASOUND SYSTEM (July 9, 2002)
  • K010950 — CYPRESS SYSTEM (June 27, 2001)
  • K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (December 1, 2000)
  • K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (December 15, 1999)
  • K992580 — FETAL ASSESSMENT CAP (October 18, 1999)
  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)

Other clearances for product code MAA

  • K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (October 28, 2010)
  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K915138 — GE SONOCHROME (October 20, 1992)
  • K905536 — FETAL DOPPLER (April 21, 1992)
  • K905456 — L328 TRANSDUCER (May 28, 1991)
  • K904951 — S5192R TRANSDUCER (April 29, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 23, 1990)

FDA data resources