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FDA 510(k)

VENTIBOX

K-Number: K844160 · 1984-12-17

ApplicantSyncor Intl. Corp.
Decision Date1984-12-17
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VENTIBOX is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1984-12-17 under 510(k) number K844160. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTIBOX?

VENTIBOX is a medical device that received FDA 510(k) clearance on 1984-12-17. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K844160.

When did VENTIBOX receive FDA 510(k) clearance?

VENTIBOX received FDA 510(k) clearance on 1984-12-17, under 510(k) number K844160.

Who is the listed applicant for VENTIBOX?

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

What is the FDA product code for VENTIBOX?

The FDA product code for VENTIBOX is KPY.

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Other records listing Syncor Intl. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

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Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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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