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FDA 510(k)

VOL. VENTILATOR SETUP W/OUT NEBULIZER

K-Number: K772069 · 1977-11-15

ApplicantInspiron Corp.
Decision Date1977-11-15
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VOL. VENTILATOR SETUP W/OUT NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Inspiron Corp.. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K772069. 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 VOL. VENTILATOR SETUP W/OUT NEBULIZER?

VOL. VENTILATOR SETUP W/OUT NEBULIZER is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Inspiron Corp.. The 510(k) number is K772069.

When did VOL. VENTILATOR SETUP W/OUT NEBULIZER receive FDA 510(k) clearance?

VOL. VENTILATOR SETUP W/OUT NEBULIZER received FDA 510(k) clearance on 1977-11-15, under 510(k) number K772069.

Who is the listed applicant for VOL. VENTILATOR SETUP W/OUT NEBULIZER?

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

What is the FDA product code for VOL. VENTILATOR SETUP W/OUT NEBULIZER?

The FDA product code for VOL. VENTILATOR SETUP W/OUT NEBULIZER is BZO.

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Other records listing Inspiron 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.

K860838INSPIRON DOUBLE SWIVEL TRACH ADAPTERK850346OXYGEN CONCENTRATORK843932VAPOR-PHASE HUMIDIFIER SYS-ADVANCEDK840935MANUAL RESUSCITATION SYSTEMK841158NEBULO 28 NEBULIZER KITK840418INSPIRATORY/EXPIRATORY MUSCLE EXERCIS

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Related Devices (Code: BZO)

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.

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

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