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FDA 510(k)

HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT

K-Number: K963917 · 1997-02-25

ApplicantHolden Walker Corp.
Decision Date1997-02-25
Product CodeCAF
Advisory CommitteeAN
DecisionUnknown

Device Summary

HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Holden Walker Corp.. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K963917. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT?

HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Holden Walker Corp.. The 510(k) number is K963917.

When did HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT receive FDA 510(k) clearance?

HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT received FDA 510(k) clearance on 1997-02-25, under 510(k) number K963917.

Who is the listed applicant for HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT?

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

What is the FDA product code for HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT?

The FDA product code for HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT is CAF.

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Official Source

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