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FDA 510(k)

EMORY CARDIAC TOOL BOX

K-Number: K980914 · 1998-06-04

Decision Date1998-06-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMORY CARDIAC TOOL BOX is the device name listed in this FDA 510(k) record. The listed applicant is Emory University. It received FDA 510(k) clearance on 1998-06-04 under 510(k) number K980914. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMORY CARDIAC TOOL BOX?

EMORY CARDIAC TOOL BOX is a medical device that received FDA 510(k) clearance on 1998-06-04. The listed applicant is Emory University. The 510(k) number is K980914.

When did EMORY CARDIAC TOOL BOX receive FDA 510(k) clearance?

EMORY CARDIAC TOOL BOX received FDA 510(k) clearance on 1998-06-04, under 510(k) number K980914.

Who is the listed applicant for EMORY CARDIAC TOOL BOX?

The FDA 510(k) record lists Emory University as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMORY CARDIAC TOOL BOX?

The FDA product code for EMORY CARDIAC TOOL BOX is KPS.

Related Clinical Trials

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.

Other records listing Emory University as applicant

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.

Related Devices (Code: KPS)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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