Bard(R) Biopotential Amplifier II

FDA 510(k) K913875 · Bard Electrophysiology

Substantially Equivalent

510(k) numberK913875

Submission

Device name
Bard(R) Biopotential Amplifier II
Applicant
Bard Electrophysiology
Tewksbury, MA, US
Received
August 29, 1991
Decision date
November 27, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRQ – Amplifier And Signal Conditioner, Transducer Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2060
Specialty
Cardiovascular

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Questions and answers

When was Bard(R) Biopotential Amplifier II cleared by the FDA?

Bard(R) Biopotential Amplifier II (K913875) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 90 days after the submission was received.

What is the product code of K913875?

The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.