DCG Preamplifier Module

FDA 510(k) K780572 · C-V Monitors Corp.

Substantially Equivalent

510(k) numberK780572

Submission

Device name
DCG Preamplifier Module
Applicant
C-V Monitors Corp.
Mchenry, IL, US
Received
April 10, 1978
Decision date
May 9, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K925346Ep Amp, Model #901DRR · Traditional Quinton Electrophysiology Corp.04/30/1993SE
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

More from Fisher Imaging Corp.

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K780571Blood Pressure ModuleDRQ · Traditional 05/09/1978SE

Questions and answers

When was DCG Preamplifier Module cleared by the FDA?

DCG Preamplifier Module (K780572) received a 510(k) decision of Substantially Equivalent on May 9, 1978, 29 days after the submission was received.

What is the product code of K780572?

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