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FDA 510(k)

ACCUTORR CSM SYSTEM

K-Number: K842538 · 1985-03-01

ApplicantDatascope Corp.
Decision Date1985-03-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUTORR CSM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K842538. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTORR CSM SYSTEM?

ACCUTORR CSM SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Datascope Corp.. The 510(k) number is K842538.

When did ACCUTORR CSM SYSTEM receive FDA 510(k) clearance?

ACCUTORR CSM SYSTEM received FDA 510(k) clearance on 1985-03-01, under 510(k) number K842538.

Who is the listed applicant for ACCUTORR CSM SYSTEM?

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

What is the FDA product code for ACCUTORR CSM SYSTEM?

The FDA product code for ACCUTORR CSM SYSTEM is DXN.

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Related Devices (Code: DXN)

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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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