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FDA 510(k)

DEMAND OXYGEN SAUER DOS2 MODEL 10

K-Number: K851235 · 1985-04-30

ApplicantApplied Membrane Technology, Inc.
Decision Date1985-04-30
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEMAND OXYGEN SAUER DOS2 MODEL 10 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Membrane Technology, Inc.. It received FDA 510(k) clearance on 1985-04-30 under 510(k) number K851235. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMAND OXYGEN SAUER DOS2 MODEL 10?

DEMAND OXYGEN SAUER DOS2 MODEL 10 is a medical device that received FDA 510(k) clearance on 1985-04-30. The listed applicant is Applied Membrane Technology, Inc.. The 510(k) number is K851235.

When did DEMAND OXYGEN SAUER DOS2 MODEL 10 receive FDA 510(k) clearance?

DEMAND OXYGEN SAUER DOS2 MODEL 10 received FDA 510(k) clearance on 1985-04-30, under 510(k) number K851235.

Who is the listed applicant for DEMAND OXYGEN SAUER DOS2 MODEL 10?

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

What is the FDA product code for DEMAND OXYGEN SAUER DOS2 MODEL 10?

The FDA product code for DEMAND OXYGEN SAUER DOS2 MODEL 10 is NFB.

Related Clinical Trials

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Other records listing Applied Membrane Technology, 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.

K870835ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)K861423DEMAND OXYGEN SAVER SYSTEM (D02S)

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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