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FDA 510(k)

VENOUS RESERVOIR BAG BMR-1600

K-Number: K851376 · 1985-06-25

ApplicantAmerican Bentley
Decision Date1985-06-25
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENOUS RESERVOIR BAG BMR-1600 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K851376. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOUS RESERVOIR BAG BMR-1600?

VENOUS RESERVOIR BAG BMR-1600 is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is American Bentley. The 510(k) number is K851376.

When did VENOUS RESERVOIR BAG BMR-1600 receive FDA 510(k) clearance?

VENOUS RESERVOIR BAG BMR-1600 received FDA 510(k) clearance on 1985-06-25, under 510(k) number K851376.

Who is the listed applicant for VENOUS RESERVOIR BAG BMR-1600?

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

What is the FDA product code for VENOUS RESERVOIR BAG BMR-1600?

The FDA product code for VENOUS RESERVOIR BAG BMR-1600 is DTN.

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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.

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