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FDA 510(k)

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5

K-Number: K072163 · 2008-03-06

Applicant3A Health Care S.R.L.
Decision Date2008-03-06
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 is the device name listed in this FDA 510(k) record. The listed applicant is 3A Health Care S.R.L.. It received FDA 510(k) clearance on 2008-03-06 under 510(k) number K072163. 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 HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5?

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 is a medical device that received FDA 510(k) clearance on 2008-03-06. The listed applicant is 3A Health Care S.R.L.. The 510(k) number is K072163.

When did HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 receive FDA 510(k) clearance?

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 received FDA 510(k) clearance on 2008-03-06, under 510(k) number K072163.

Who is the listed applicant for HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5?

The FDA 510(k) record lists 3A Health Care S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5?

The FDA product code for HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 is CAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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