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FDA 510(k)

INFANT ECG ELECTRODE #60-1029

K-Number: K810102 · 1981-01-29

ApplicantAspen Laboratories, Inc.
Decision Date1981-01-29
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFANT ECG ELECTRODE #60-1029 is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-29 under 510(k) number K810102. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT ECG ELECTRODE #60-1029?

INFANT ECG ELECTRODE #60-1029 is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K810102.

When did INFANT ECG ELECTRODE #60-1029 receive FDA 510(k) clearance?

INFANT ECG ELECTRODE #60-1029 received FDA 510(k) clearance on 1981-01-29, under 510(k) number K810102.

Who is the listed applicant for INFANT ECG ELECTRODE #60-1029?

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

What is the FDA product code for INFANT ECG ELECTRODE #60-1029?

The FDA product code for INFANT ECG ELECTRODE #60-1029 is DRX.

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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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