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FDA 510(k)

UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION

K-Number: K911328 · 1991-08-15

ApplicantIntertech Resources, Inc.
Decision Date1991-08-15
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Intertech Resources, Inc.. It received FDA 510(k) clearance on 1991-08-15 under 510(k) number K911328. 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 UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION?

UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-08-15. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K911328.

When did UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION receive FDA 510(k) clearance?

UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION received FDA 510(k) clearance on 1991-08-15, under 510(k) number K911328.

Who is the listed applicant for UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION?

The FDA 510(k) record lists Intertech Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION?

The FDA product code for UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION is BZO.

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Other records listing Intertech Resources, Inc. 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.

K9613181ST RESPONSE DISPOSABLE MANOMETERK955008HEAT & MOISTURE EXCHANGERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952062PFT FILTERK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC

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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.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952011PRIMA BREATHING BAGSPrima, 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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