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FDA 510(k)

NDM INFANT ECG PACKPAD

K-Number: K780631 · 1978-05-03

ApplicantNew Dimensions IN Medicine, Inc.
Decision Date1978-05-03
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NDM INFANT ECG PACKPAD is the device name listed in this FDA 510(k) record. The listed applicant is New Dimensions IN Medicine, Inc.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780631. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDM INFANT ECG PACKPAD?

NDM INFANT ECG PACKPAD is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is New Dimensions IN Medicine, Inc.. The 510(k) number is K780631.

When did NDM INFANT ECG PACKPAD receive FDA 510(k) clearance?

NDM INFANT ECG PACKPAD received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780631.

Who is the listed applicant for NDM INFANT ECG PACKPAD?

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

What is the FDA product code for NDM INFANT ECG PACKPAD?

The FDA product code for NDM INFANT ECG PACKPAD is GYB.

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Other records listing New Dimensions IN Medicine, Inc. as applicant

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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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