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FDA 510(k)

HSINER NEBULIZER BOTTLE

K-Number: K070948 · 2007-04-25

ApplicantHsiner
Decision Date2007-04-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HSINER NEBULIZER BOTTLE is the device name listed in this FDA 510(k) record. The listed applicant is Hsiner. It received FDA 510(k) clearance on 2007-04-25 under 510(k) number K070948. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSINER NEBULIZER BOTTLE?

HSINER NEBULIZER BOTTLE is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Hsiner. The 510(k) number is K070948.

When did HSINER NEBULIZER BOTTLE receive FDA 510(k) clearance?

HSINER NEBULIZER BOTTLE received FDA 510(k) clearance on 2007-04-25, under 510(k) number K070948.

Who is the listed applicant for HSINER NEBULIZER BOTTLE?

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

What is the FDA product code for HSINER NEBULIZER BOTTLE?

The FDA product code for HSINER NEBULIZER BOTTLE is CAF.

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Official Source

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