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FDA 510(k)

BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT

K-Number: K853652 · 1986-01-16

ApplicantFisher Imaging Corp.
Decision Date1986-01-16
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Imaging Corp.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K853652. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT?

BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Fisher Imaging Corp.. The 510(k) number is K853652.

When did BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT receive FDA 510(k) clearance?

BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT received FDA 510(k) clearance on 1986-01-16, under 510(k) number K853652.

Who is the listed applicant for BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT?

The FDA 510(k) record lists Fisher Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT?

The FDA product code for BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT is DRR.

Related Clinical Trials

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Other records listing Fisher Imaging Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952456IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMK870783BPA CARDIOVASCULAR PRESSURE AMPLIFIER

Related Devices (Code: DRR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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