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FDA 510(k)

DEMAND OXYGEN CONTROLLER

K-Number: K833351 · 1984-03-19

ApplicantHealthdyne, Inc.
Decision Date1984-03-19
Product CodeBZB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEMAND OXYGEN CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K833351. The device is classified under product code BZB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMAND OXYGEN CONTROLLER?

DEMAND OXYGEN CONTROLLER is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Healthdyne, Inc.. The 510(k) number is K833351.

When did DEMAND OXYGEN CONTROLLER receive FDA 510(k) clearance?

DEMAND OXYGEN CONTROLLER received FDA 510(k) clearance on 1984-03-19, under 510(k) number K833351.

Who is the listed applicant for DEMAND OXYGEN CONTROLLER?

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

What is the FDA product code for DEMAND OXYGEN CONTROLLER?

The FDA product code for DEMAND OXYGEN CONTROLLER is BZB.

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Other records listing Healthdyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER SYSTEM

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Related Devices (Code: BZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K896731OXYGEN CATHETERSUnoplast A/SK843466PHARMA-PLAST OXYGEN CATHETERZimmar Consulting , Ltd.K830984OXYGEN CATHETERSMedovations, Inc.K820370NASAL OXYGEN CATHETERAmerican Pharmaseal Div. AhscK800506OXYGEN CATHETERMedi-Craft , Ltd.K791273CONPHAR OXYGEN CATHETER-STERILEConphar, Inc.

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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