FDA 510(k)

VENTILATOR CIRCUIT

K-Number: K812774 · 1981-10-23

ApplicantHudson Oxygen Therapy Sales Co.

Decision Date1981-10-23

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VENTILATOR CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Oxygen Therapy Sales Co.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812774. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTILATOR CIRCUIT?

VENTILATOR CIRCUIT is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Hudson Oxygen Therapy Sales Co.. The 510(k) number is K812774.

When did VENTILATOR CIRCUIT receive FDA 510(k) clearance?

VENTILATOR CIRCUIT received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812774.

Who is the listed applicant for VENTILATOR CIRCUIT?

The FDA 510(k) record lists Hudson Oxygen Therapy Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTILATOR CIRCUIT?

The FDA product code for VENTILATOR CIRCUIT is BZO.

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Other records listing Hudson Oxygen Therapy Sales Co. as applicant

K902062PEEP VALVE K900783MDI ADAPTOR K900470IN-THE NEBULIZER K895589MANUAL RESUSCITATOR K896136INFANT C.P.A.P. MONITOR K895747VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR

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Related Devices (Code: BZO)

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.

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.