FDA 510(k)

CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004

K-Number: K893760 · 1989-08-10

Decision Date1989-08-10

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 is the device name listed in this FDA 510(k) record. The listed applicant is Nova-Ventrx. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K893760. 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 CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004?

CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Nova-Ventrx. The 510(k) number is K893760.

When did CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 receive FDA 510(k) clearance?

CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 received FDA 510(k) clearance on 1989-08-10, under 510(k) number K893760.

Who is the listed applicant for CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004?

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

What is the FDA product code for CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004?

The FDA product code for CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 is BZO.

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Other records listing Nova-Ventrx as applicant

K952267CRITERION, CRITERION I.V., MODIFIED K954480CONDENSATE COLLECTION KIT K881207RES-Q 1, 2, 3, 4 AND 5 K870382DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 K863756MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT K850600CO-AX VENTILATOR CIRCUIT

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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.