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FDA 510(k)

ECHOCARDIOGRAPHY SYS., MODEL 3830

K-Number: K770755 · 1977-05-09

ApplicantHoneywell, Inc.
Decision Date1977-05-09
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOCARDIOGRAPHY SYS., MODEL 3830 is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1977-05-09 under 510(k) number K770755. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOCARDIOGRAPHY SYS., MODEL 3830?

ECHOCARDIOGRAPHY SYS., MODEL 3830 is a medical device that received FDA 510(k) clearance on 1977-05-09. The listed applicant is Honeywell, Inc.. The 510(k) number is K770755.

When did ECHOCARDIOGRAPHY SYS., MODEL 3830 receive FDA 510(k) clearance?

ECHOCARDIOGRAPHY SYS., MODEL 3830 received FDA 510(k) clearance on 1977-05-09, under 510(k) number K770755.

Who is the listed applicant for ECHOCARDIOGRAPHY SYS., MODEL 3830?

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 ECHOCARDIOGRAPHY SYS., MODEL 3830?

The FDA product code for ECHOCARDIOGRAPHY SYS., MODEL 3830 is DXK.

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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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