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510(k) K842539

DIAGNOSTIC ULTRASOUND 105 & 110 by Diagnostic Ultrasound Corp. — Product Code JOP

K842539 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "DIAGNOSTIC ULTRASOUND 105 & 110". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
June 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances by Diagnostic Ultrasound Corp.

  • K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM (March 26, 2003)
  • K022153 — BLADDERSCAN BVI 6100 (August 15, 2002)
  • K982568 — BLADDERMANAGER PCI 5000 MODEL 1002 (January 25, 1999)
  • K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 (October 1, 1996)
  • K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 (May 24, 1996)
  • K955942 — BLADDERSCAN BVI 5000 (March 15, 1996)
  • K920664 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION (December 23, 1993)
  • K915342 — UD 2000 VIDEO OPTION (June 10, 1992)
  • K915436 — BLADDERSCAN BVI 2500 (March 3, 1992)
  • K911166 — DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (August 15, 1991)

Other clearances for product code JOP

  • K242662 — Falcon/Xpress (Falcon/Xpress) (December 18, 2024)
  • K233976 — VasoGuard (V10, V8, V6, V4, V2) (July 19, 2024)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (September 27, 2013)
  • K111416 — FALCON (July 15, 2011)
  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)

FDA data resources