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FDA 510(k)

MODEL 381 HOME OXYGEN SENTRY

K-Number: K811702 · 1981-07-16

ApplicantStanley Aviation Corp.
Decision Date1981-07-16
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 381 HOME OXYGEN SENTRY is the device name listed in this FDA 510(k) record. The listed applicant is Stanley Aviation Corp.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811702. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 381 HOME OXYGEN SENTRY?

MODEL 381 HOME OXYGEN SENTRY is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Stanley Aviation Corp.. The 510(k) number is K811702.

When did MODEL 381 HOME OXYGEN SENTRY receive FDA 510(k) clearance?

MODEL 381 HOME OXYGEN SENTRY received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811702.

Who is the listed applicant for MODEL 381 HOME OXYGEN SENTRY?

The FDA 510(k) record lists Stanley Aviation Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 381 HOME OXYGEN SENTRY?

The FDA product code for MODEL 381 HOME OXYGEN SENTRY is CCL.

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 Stanley Aviation Corp. 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.

K801523MODEL 379 WXYGEN CONCENTRATOR

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

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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