FDA 510(k)

SAMS 8000 CARDIOPLEGIA MONITOR

K-Number: K960916 · 1996-06-04

Decision Date1996-06-04

Product CodeDSJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SAMS 8000 CARDIOPLEGIA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1996-06-04 under 510(k) number K960916. The device is classified under product code DSJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMS 8000 CARDIOPLEGIA MONITOR?

SAMS 8000 CARDIOPLEGIA MONITOR is a medical device that received FDA 510(k) clearance on 1996-06-04. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K960916.

When did SAMS 8000 CARDIOPLEGIA MONITOR receive FDA 510(k) clearance?

SAMS 8000 CARDIOPLEGIA MONITOR received FDA 510(k) clearance on 1996-06-04, under 510(k) number K960916.

Who is the listed applicant for SAMS 8000 CARDIOPLEGIA MONITOR?

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

What is the FDA product code for SAMS 8000 CARDIOPLEGIA MONITOR?

The FDA product code for SAMS 8000 CARDIOPLEGIA MONITOR is DSJ.

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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.