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FDA 510(k)

RESPIRATION/APNEA AMPLIFIER MODEL 3105

K-Number: K792528 · 1980-02-21

ApplicantElectronics For Medicine, Inc.
Decision Date1980-02-21
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION/APNEA AMPLIFIER MODEL 3105 is the device name listed in this FDA 510(k) record. The listed applicant is Electronics For Medicine, Inc.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K792528. 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 RESPIRATION/APNEA AMPLIFIER MODEL 3105?

RESPIRATION/APNEA AMPLIFIER MODEL 3105 is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Electronics For Medicine, Inc.. The 510(k) number is K792528.

When did RESPIRATION/APNEA AMPLIFIER MODEL 3105 receive FDA 510(k) clearance?

RESPIRATION/APNEA AMPLIFIER MODEL 3105 received FDA 510(k) clearance on 1980-02-21, under 510(k) number K792528.

Who is the listed applicant for RESPIRATION/APNEA AMPLIFIER MODEL 3105?

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

What is the FDA product code for RESPIRATION/APNEA AMPLIFIER MODEL 3105?

The FDA product code for RESPIRATION/APNEA AMPLIFIER MODEL 3105 is BZQ.

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Other records listing Electronics For Medicine, 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.

K830791UNIVERSAL MEDDARS SYSTEMK830795CABINET FOR MULTIPLE FUNCTION BLOCKSK791006SMART BILECTRODESK790198MONITOR PLUG-IN MODEL M1106 ECGK790203INTERVAL TIMER MODEL V4295K790185MODEL V 4207 INTEGRATING PLUG-IN

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Related Devices (Code: BZQ)

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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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