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510(k) K892944

INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 by Interspec, Inc. — Product Code JOP

K892944 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515". The FDA issued a decision of Substantially Equivalent on July 19, 1989. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Interspec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1989
Date Received
April 21, 1989
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 Interspec, Inc.

  • K940671 — INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETE (November 22, 1994)
  • K924231 — INTERSPEC APOGEE CLA (June 14, 1993)
  • K915696 — INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE (November 24, 1992)
  • K920678 — ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (April 2, 1992)
  • K911073 — PROBE REFILL KIT (June 6, 1991)
  • K910049 — INTERSPEC APOGEE, MODIFICATION (April 29, 1991)
  • K903839 — INTERSPEC APOGEE (November 16, 1990)
  • K900155 — INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER (October 5, 1990)
  • K890173 — INTERSPEC APOGEE (April 14, 1989)
  • K863372 — SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES (November 4, 1986)

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