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FDA 510(k)

DEMAND OXYGEN SAVER SYSTEM (D02S)

K-Number: K861423 · 1986-05-16

ApplicantApplied Membrane Technology, Inc.
Decision Date1986-05-16
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEMAND OXYGEN SAVER SYSTEM (D02S) 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 1986-05-16 under 510(k) number K861423. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMAND OXYGEN SAVER SYSTEM (D02S)?

DEMAND OXYGEN SAVER SYSTEM (D02S) is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Applied Membrane Technology, Inc.. The 510(k) number is K861423.

When did DEMAND OXYGEN SAVER SYSTEM (D02S) receive FDA 510(k) clearance?

DEMAND OXYGEN SAVER SYSTEM (D02S) received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861423.

Who is the listed applicant for DEMAND OXYGEN SAVER SYSTEM (D02S)?

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 SAVER SYSTEM (D02S)?

The FDA product code for DEMAND OXYGEN SAVER SYSTEM (D02S) is BZQ.

Related Clinical Trials

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.

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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)K851235DEMAND OXYGEN SAUER DOS2 MODEL 10

Related Devices (Code: BZQ)

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.

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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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