FDA 510(k)

RED DOT 2515 CARDIAC SENSOR SYSTEM

K-Number: K924487 · 1992-12-23

Decision Date1992-12-23

Product CodeBRX

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RED DOT 2515 CARDIAC SENSOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Ltd.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K924487. The device is classified under product code BRX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED DOT 2515 CARDIAC SENSOR SYSTEM?

RED DOT 2515 CARDIAC SENSOR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is 3M Health Care, Ltd.. The 510(k) number is K924487.

When did RED DOT 2515 CARDIAC SENSOR SYSTEM receive FDA 510(k) clearance?

RED DOT 2515 CARDIAC SENSOR SYSTEM received FDA 510(k) clearance on 1992-12-23, under 510(k) number K924487.

Who is the listed applicant for RED DOT 2515 CARDIAC SENSOR SYSTEM?

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

What is the FDA product code for RED DOT 2515 CARDIAC SENSOR SYSTEM?

The FDA product code for RED DOT 2515 CARDIAC SENSOR SYSTEM is BRX.

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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.