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FDA 510(k)

HELIOX LOW FLOW SENTRY BLENDER

K-Number: K092484 · 2010-04-02

ApplicantCardinal Health 207, Inc.
Decision Date2010-04-02
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HELIOX LOW FLOW SENTRY BLENDER is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 207, Inc.. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K092484. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOX LOW FLOW SENTRY BLENDER?

HELIOX LOW FLOW SENTRY BLENDER is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Cardinal Health 207, Inc.. The 510(k) number is K092484.

When did HELIOX LOW FLOW SENTRY BLENDER receive FDA 510(k) clearance?

HELIOX LOW FLOW SENTRY BLENDER received FDA 510(k) clearance on 2010-04-02, under 510(k) number K092484.

Who is the listed applicant for HELIOX LOW FLOW SENTRY BLENDER?

The FDA 510(k) record lists Cardinal Health 207, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIOX LOW FLOW SENTRY BLENDER?

The FDA product code for HELIOX LOW FLOW SENTRY BLENDER is BZR.

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Other records listing Cardinal Health 207, 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.

K093094VELA VENTILATORK093124PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03K081670THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASKK081837AVEA VENTILATOR

Related Devices (Code: BZR)

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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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