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FDA 510(k)

STERILE WATER FOR INHALATION FLEX BAG, USP

K-Number: K090915 · 2009-11-18

ApplicantCardinal Health, Inc.
Decision Date2009-11-18
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STERILE WATER FOR INHALATION FLEX BAG, USP is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2009-11-18 under 510(k) number K090915. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE WATER FOR INHALATION FLEX BAG, USP?

STERILE WATER FOR INHALATION FLEX BAG, USP is a medical device that received FDA 510(k) clearance on 2009-11-18. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K090915.

When did STERILE WATER FOR INHALATION FLEX BAG, USP receive FDA 510(k) clearance?

STERILE WATER FOR INHALATION FLEX BAG, USP received FDA 510(k) clearance on 2009-11-18, under 510(k) number K090915.

Who is the listed applicant for STERILE WATER FOR INHALATION FLEX BAG, USP?

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

What is the FDA product code for STERILE WATER FOR INHALATION FLEX BAG, USP?

The FDA product code for STERILE WATER FOR INHALATION FLEX BAG, USP is BTT.

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Other records listing Cardinal Health, Inc. as applicant

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Related Devices (Code: BTT)

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.

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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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