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FDA 510(k)

APPLICARD (EKG)

K-Number: K900459 · 1990-07-31

ApplicantMedi-Globe Corp.
Decision Date1990-07-31
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPLICARD (EKG) is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corp.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K900459. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLICARD (EKG)?

APPLICARD (EKG) is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Medi-Globe Corp.. The 510(k) number is K900459.

When did APPLICARD (EKG) receive FDA 510(k) clearance?

APPLICARD (EKG) received FDA 510(k) clearance on 1990-07-31, under 510(k) number K900459.

Who is the listed applicant for APPLICARD (EKG)?

The FDA 510(k) record lists Medi-Globe Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLICARD (EKG)?

The FDA product code for APPLICARD (EKG) is DRY.

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Other records listing Medi-Globe Corp. as applicant

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Related Devices (Code: DRY)

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.

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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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