Q-Dop

FDA 510(k) K843058 · Quinton, Inc.

Substantially Equivalent

510(k) numberK843058

Submission

Device name
Q-Dop
Applicant
Quinton, Inc.
Seattle, WA, US
Received
August 3, 1984
Decision date
April 10, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JOP – Transducer, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2880
Specialty
Cardiovascular

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K153762Smartdop XT6JOP · Traditional Koven Technology, Inc.05/25/2016SE
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K111416FalconJOP · Traditional Viasonix , Ltd.07/15/2011SE
K071730Studiodop VicorderJOP · Abbreviated Skidmore Medical, Limited12/20/2007SE
K010482Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special Echocath, Inc.03/20/2001SE
K002766Nicolet VasoguardJOP · Abbreviated Nicolet Biomedical11/30/2000SE
K990642Echoflow Doppler Blood Velocity MeterJOP · Traditional Echocath, Inc.09/16/1999SE

More from Echocath, Inc.

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K001492Quinton Q-Stress, Model 000483DPS · Abbreviated 08/09/2000SE
K992908Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional 03/06/2000SE
K990866Quinton Medtrack CR Plus TreadmillISD · Traditional 04/29/1999SE
K971397Viewcath 3-D Catheter PullbackITX · Traditional 08/25/1997SE
K964784Synergy Cardiology Information System (00431)DPS · Traditional 08/13/1997SE
K964978Vital Statistics System (O-Cath Accessory)DQA · Traditional 05/21/1997SE
K955002Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional 09/13/1996SE

Questions and answers

When was Q-Dop cleared by the FDA?

Q-Dop (K843058) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 250 days after the submission was received.

What is the product code of K843058?

The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.