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FDA 510(k)

MODEL 2000 MONITOR

K-Number: K812828 · 1981-11-16

ApplicantDatascope Corp.
Decision Date1981-11-16
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 2000 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812828. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 2000 MONITOR?

MODEL 2000 MONITOR is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Datascope Corp.. The 510(k) number is K812828.

When did MODEL 2000 MONITOR receive FDA 510(k) clearance?

MODEL 2000 MONITOR received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812828.

Who is the listed applicant for MODEL 2000 MONITOR?

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 MODEL 2000 MONITOR?

The FDA product code for MODEL 2000 MONITOR is DRT.

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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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