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FDA 510(k)

BREATHE EASY, MODELS AD AND CD

K-Number: K981841 · 1998-10-13

ApplicantRespiraid , Ltd.
Decision Date1998-10-13
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BREATHE EASY, MODELS AD AND CD is the device name listed in this FDA 510(k) record. The listed applicant is Respiraid , Ltd.. It received FDA 510(k) clearance on 1998-10-13 under 510(k) number K981841. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHE EASY, MODELS AD AND CD?

BREATHE EASY, MODELS AD AND CD is a medical device that received FDA 510(k) clearance on 1998-10-13. The listed applicant is Respiraid , Ltd.. The 510(k) number is K981841.

When did BREATHE EASY, MODELS AD AND CD receive FDA 510(k) clearance?

BREATHE EASY, MODELS AD AND CD received FDA 510(k) clearance on 1998-10-13, under 510(k) number K981841.

Who is the listed applicant for BREATHE EASY, MODELS AD AND CD?

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

What is the FDA product code for BREATHE EASY, MODELS AD AND CD?

The FDA product code for BREATHE EASY, MODELS AD AND CD is FRF.

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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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