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FDA 510(k)

MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)

K-Number: K853084 · 1985-08-02

ApplicantAequitron Medical, Inc.
Decision Date1985-08-02
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K853084. 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 MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)?

MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K853084.

When did MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) receive FDA 510(k) clearance?

MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) received FDA 510(k) clearance on 1985-08-02, under 510(k) number K853084.

Who is the listed applicant for MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)?

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

What is the FDA product code for MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)?

The FDA product code for MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) is 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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