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FDA 510(k)

OECO APNEA MONITOR

K-Number: K811628 · 1981-07-31

ApplicantOeco
Decision Date1981-07-31
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OECO APNEA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Oeco. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K811628. 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 OECO APNEA MONITOR?

OECO APNEA MONITOR is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Oeco. The 510(k) number is K811628.

When did OECO APNEA MONITOR receive FDA 510(k) clearance?

OECO APNEA MONITOR received FDA 510(k) clearance on 1981-07-31, under 510(k) number K811628.

Who is the listed applicant for OECO APNEA MONITOR?

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

What is the FDA product code for OECO APNEA MONITOR?

The FDA product code for OECO APNEA MONITOR 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 Oeco 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.

K811789OECO NASAL CANNULA

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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