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FDA 510(k)

RED DOT CARDIAC SENSOR SYSTEM

K-Number: K896155 · 1989-12-13

Applicant3M Company
Decision Date1989-12-13
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RED DOT CARDIAC SENSOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K896155. 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 RED DOT CARDIAC SENSOR SYSTEM?

RED DOT CARDIAC SENSOR SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is 3M Company. The 510(k) number is K896155.

When did RED DOT CARDIAC SENSOR SYSTEM receive FDA 510(k) clearance?

RED DOT CARDIAC SENSOR SYSTEM received FDA 510(k) clearance on 1989-12-13, under 510(k) number K896155.

Who is the listed applicant for RED DOT CARDIAC SENSOR SYSTEM?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RED DOT CARDIAC SENSOR SYSTEM?

The FDA product code for RED DOT CARDIAC SENSOR SYSTEM is DRX.

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 3M Company 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.

View all 322 devices →

Related Devices (Code: DRX)

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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