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FDA 510(k)

AMPLIFIER OTRONA, MODEL N3A-EMG

K-Number: K772102 · 1977-11-21

ApplicantHoneywell, Inc.
Decision Date1977-11-21
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMPLIFIER OTRONA, MODEL N3A-EMG is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1977-11-21 under 510(k) number K772102. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLIFIER OTRONA, MODEL N3A-EMG?

AMPLIFIER OTRONA, MODEL N3A-EMG is a medical device that received FDA 510(k) clearance on 1977-11-21. The listed applicant is Honeywell, Inc.. The 510(k) number is K772102.

When did AMPLIFIER OTRONA, MODEL N3A-EMG receive FDA 510(k) clearance?

AMPLIFIER OTRONA, MODEL N3A-EMG received FDA 510(k) clearance on 1977-11-21, under 510(k) number K772102.

Who is the listed applicant for AMPLIFIER OTRONA, MODEL N3A-EMG?

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 OTRONA, MODEL N3A-EMG?

The FDA product code for AMPLIFIER OTRONA, MODEL N3A-EMG is GWL.

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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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