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FDA 510(k)

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

K-Number: K913692 · 1991-11-15

ApplicantBentley Laboratories, Inc.
Decision Date1991-11-15
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1991-11-15 under 510(k) number K913692. 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 MODEL NO. BMR-250(TM)?

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K913692.

When did VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) receive FDA 510(k) clearance?

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) received FDA 510(k) clearance on 1991-11-15, under 510(k) number K913692.

Who is the listed applicant for VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)?

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

What is the FDA product code for VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)?

The FDA product code for VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) is DTN.

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Related Devices (Code: 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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