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FDA 510(k)

M/D4 W/CHARGER (CARDIOPAC 3M11)

K-Number: K844447 · 1985-01-14

ApplicantDatascope Corp.
Decision Date1985-01-14
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M/D4 W/CHARGER (CARDIOPAC 3M11) is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K844447. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M/D4 W/CHARGER (CARDIOPAC 3M11)?

M/D4 W/CHARGER (CARDIOPAC 3M11) is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is Datascope Corp.. The 510(k) number is K844447.

When did M/D4 W/CHARGER (CARDIOPAC 3M11) receive FDA 510(k) clearance?

M/D4 W/CHARGER (CARDIOPAC 3M11) received FDA 510(k) clearance on 1985-01-14, under 510(k) number K844447.

Who is the listed applicant for M/D4 W/CHARGER (CARDIOPAC 3M11)?

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 M/D4 W/CHARGER (CARDIOPAC 3M11)?

The FDA product code for M/D4 W/CHARGER (CARDIOPAC 3M11) is LDD.

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Related Devices (Code: LDD)

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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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