FDA 510(k)

TUBING, AEROSAL, DISPOSABLE

K-Number: K770354 · 1977-03-16

Decision Date1977-03-16

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TUBING, AEROSAL, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Inhal-O-Tech Medical Plastic. It received FDA 510(k) clearance on 1977-03-16 under 510(k) number K770354. 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 TUBING, AEROSAL, DISPOSABLE?

TUBING, AEROSAL, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1977-03-16. The listed applicant is Inhal-O-Tech Medical Plastic. The 510(k) number is K770354.

When did TUBING, AEROSAL, DISPOSABLE receive FDA 510(k) clearance?

TUBING, AEROSAL, DISPOSABLE received FDA 510(k) clearance on 1977-03-16, under 510(k) number K770354.

Who is the listed applicant for TUBING, AEROSAL, DISPOSABLE?

The FDA 510(k) record lists Inhal-O-Tech Medical Plastic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUBING, AEROSAL, DISPOSABLE?

The FDA product code for TUBING, AEROSAL, DISPOSABLE is BZO.

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Other records listing Inhal-O-Tech Medical Plastic as applicant

K781741MASK, BI FLO NASAL OXYGEN K781394DISPOSABLE INCENTIVE SPIROMETER K781395DISPOSABLE AEROSOL T BRIGGS ADAPTOR K770353DISPOSABLE TEMPERATURE PROBE K760329MASK, DISPOSABLE OXYGEN THERAPY K760330CANNULA, DISPOSABLE OXYGEN TTHERAPY

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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.