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FDA 510(k)

EMERSON 33-CR CHEST RESPIRATOR

K-Number: K894649 · 1989-10-13

ApplicantEmerson Intl. Co.
Decision Date1989-10-13
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMERSON 33-CR CHEST RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Emerson Intl. Co.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K894649. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERSON 33-CR CHEST RESPIRATOR?

EMERSON 33-CR CHEST RESPIRATOR is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Emerson Intl. Co.. The 510(k) number is K894649.

When did EMERSON 33-CR CHEST RESPIRATOR receive FDA 510(k) clearance?

EMERSON 33-CR CHEST RESPIRATOR received FDA 510(k) clearance on 1989-10-13, under 510(k) number K894649.

Who is the listed applicant for EMERSON 33-CR CHEST RESPIRATOR?

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

What is the FDA product code for EMERSON 33-CR CHEST RESPIRATOR?

The FDA product code for EMERSON 33-CR CHEST RESPIRATOR is BYT.

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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Related Devices (Code: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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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