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FDA 510(k)

TRACHEA/CUFF INFLATOR W/PRESSURE #583

K-Number: K831577 · 1983-07-07

ApplicantMedical Electronics Corp.
Decision Date1983-07-07
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEA/CUFF INFLATOR W/PRESSURE #583 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronics Corp.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831577. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEA/CUFF INFLATOR W/PRESSURE #583?

TRACHEA/CUFF INFLATOR W/PRESSURE #583 is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Medical Electronics Corp.. The 510(k) number is K831577.

When did TRACHEA/CUFF INFLATOR W/PRESSURE #583 receive FDA 510(k) clearance?

TRACHEA/CUFF INFLATOR W/PRESSURE #583 received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831577.

Who is the listed applicant for TRACHEA/CUFF INFLATOR W/PRESSURE #583?

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

What is the FDA product code for TRACHEA/CUFF INFLATOR W/PRESSURE #583?

The FDA product code for TRACHEA/CUFF INFLATOR W/PRESSURE #583 is BSK.

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Other records listing Medical Electronics 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.

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Related Devices (Code: BSK)

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.

K261499TrachFlushAw Technologies ApsK243562CuffGuardIdmedK242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies ApsK221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

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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