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FDA 510(k)

BIVONA VENTILATOR ISOLATOR SYSTEM

K-Number: K890499 · 1989-06-15

ApplicantBivona Medical Technologies
Decision Date1989-06-15
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIVONA VENTILATOR ISOLATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1989-06-15 under 510(k) number K890499. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIVONA VENTILATOR ISOLATOR SYSTEM?

BIVONA VENTILATOR ISOLATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Bivona Medical Technologies. The 510(k) number is K890499.

When did BIVONA VENTILATOR ISOLATOR SYSTEM receive FDA 510(k) clearance?

BIVONA VENTILATOR ISOLATOR SYSTEM received FDA 510(k) clearance on 1989-06-15, under 510(k) number K890499.

Who is the listed applicant for BIVONA VENTILATOR ISOLATOR SYSTEM?

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

What is the FDA product code for BIVONA VENTILATOR ISOLATOR SYSTEM?

The FDA product code for BIVONA VENTILATOR ISOLATOR SYSTEM is CAI.

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Other records listing Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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