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FDA 510(k)

D100 COMPUTER CARDIAC ANALYSIS SYSTEM

K-Number: K863231 · 1986-11-25

ApplicantDextra Medical, Inc.
Decision Date1986-11-25
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D100 COMPUTER CARDIAC ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dextra Medical, Inc.. It received FDA 510(k) clearance on 1986-11-25 under 510(k) number K863231. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D100 COMPUTER CARDIAC ANALYSIS SYSTEM?

D100 COMPUTER CARDIAC ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Dextra Medical, Inc.. The 510(k) number is K863231.

When did D100 COMPUTER CARDIAC ANALYSIS SYSTEM receive FDA 510(k) clearance?

D100 COMPUTER CARDIAC ANALYSIS SYSTEM received FDA 510(k) clearance on 1986-11-25, under 510(k) number K863231.

Who is the listed applicant for D100 COMPUTER CARDIAC ANALYSIS SYSTEM?

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

What is the FDA product code for D100 COMPUTER CARDIAC ANALYSIS SYSTEM?

The FDA product code for D100 COMPUTER CARDIAC ANALYSIS SYSTEM is DXG.

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.

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Other records listing Dextra Medical, Inc. 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.

K863230D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM

Related Devices (Code: DXG)

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

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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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