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FDA 510(k)

AMPLIFIER MODEL N5A-HIS

K-Number: K771685 · 1977-09-14

ApplicantHoneywell, Inc.
Decision Date1977-09-14
Product CodeDRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLIFIER MODEL N5A-HIS is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1977-09-14 under 510(k) number K771685. The device is classified under product code DRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLIFIER MODEL N5A-HIS?

AMPLIFIER MODEL N5A-HIS is a medical device that received FDA 510(k) clearance on 1977-09-14. The listed applicant is Honeywell, Inc.. The 510(k) number is K771685.

When did AMPLIFIER MODEL N5A-HIS receive FDA 510(k) clearance?

AMPLIFIER MODEL N5A-HIS received FDA 510(k) clearance on 1977-09-14, under 510(k) number K771685.

Who is the listed applicant for AMPLIFIER MODEL N5A-HIS?

The FDA 510(k) record lists Honeywell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLIFIER MODEL N5A-HIS?

The FDA product code for AMPLIFIER MODEL N5A-HIS is DRJ.

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Other records listing Honeywell, Inc. 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.

K902230COLORADO COLOR IMAGING RECORDERK863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECORK853501HONEYWELL ELECTRONIC VENTILATOR EV-AK855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEMK851888APM DISPOS. BLOOD PRESSURE TRANSDUCERK851496ECG MONITOR MODEL RM102

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Related Devices (Code: DRJ)

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.

K832828CENTURION CARDIAC DETECTORClinical Data Instruments, Inc.K822590PRESSURE ISOLATION AMPLIFIER #9813 517Honeywell, Inc.K771684AMPLIFIER MODEL N5A-ECGHoneywell, 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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