Epxpress System (Timberwolf Revision) /000391

FDA 510(k) K971570 · Quinton Electrophysiology Corp.

Substantially Equivalent

510(k) numberK971570

Submission

Device name
Epxpress System (Timberwolf Revision) /000391
Applicant
Quinton Electrophysiology Corp.
Bothell, WA, US
Received
April 29, 1997
Decision date
December 29, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRR – Amplifier And Signal Conditioner, Biopotential
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2050
Specialty
Cardiovascular

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K914381Horizon 9000/HIS Option AmplifierDRR · Traditional Mennen Medical, Inc.01/28/1992SE
K911935Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional Gould, Inc.07/22/1991SE
K910307Cardiolab Amplifier Module (Cam)DRR · Traditional Prucka Engineering, Inc.04/12/1991SE
K894735ASC-952 Physiological AmplifierDRR · Traditional Astro-Med, Inc.09/18/1989SE
K894161ASC-950 ECG AmplifierDRR · Traditional Astro-Med, Inc.08/03/1989SE
K874441Bard Biopotential AmplifierDRR · Traditional C.R. Bard, Inc.01/19/1988SE
K853652BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional Fisher Imaging Corp.01/16/1986SE
K813123Epc FilterDRR · Traditional Codman & Shurtleff, Inc.11/27/1981SE

More from Codman & Shurtleff, Inc.

510(k)DeviceDecision
K925346Ep Amp, Model #901DRR · Traditional 04/30/1993SE
K893836Eplab (Electrocardiographic Monitor)DSH · Traditional 09/08/1989SE

Questions and answers

When was Epxpress System (Timberwolf Revision) /000391 cleared by the FDA?

Epxpress System (Timberwolf Revision) /000391 (K971570) received a 510(k) decision of Substantially Equivalent on December 29, 1997, 244 days after the submission was received.

What is the product code of K971570?

The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.