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FDA 510(k)

DOWNS CAP FLOW GENERATOR

K-Number: K811393 · 1981-06-09

ApplicantVital Signs, Inc.
Decision Date1981-06-09
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DOWNS CAP FLOW GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1981-06-09 under 510(k) number K811393. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOWNS CAP FLOW GENERATOR?

DOWNS CAP FLOW GENERATOR is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Vital Signs, Inc.. The 510(k) number is K811393.

When did DOWNS CAP FLOW GENERATOR receive FDA 510(k) clearance?

DOWNS CAP FLOW GENERATOR received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811393.

Who is the listed applicant for DOWNS CAP FLOW GENERATOR?

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

What is the FDA product code for DOWNS CAP FLOW GENERATOR?

The FDA product code for DOWNS CAP FLOW GENERATOR is BZR.

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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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