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FDA 510(k)

E-Z BREATHERS

K-Number: K953042 · 1995-12-08

ApplicantE-Z Kare Good Health Systems, Inc.
Decision Date1995-12-08
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

E-Z BREATHERS is the device name listed in this FDA 510(k) record. The listed applicant is E-Z Kare Good Health Systems, Inc.. It received FDA 510(k) clearance on 1995-12-08 under 510(k) number K953042. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z BREATHERS?

E-Z BREATHERS is a medical device that received FDA 510(k) clearance on 1995-12-08. The listed applicant is E-Z Kare Good Health Systems, Inc.. The 510(k) number is K953042.

When did E-Z BREATHERS receive FDA 510(k) clearance?

E-Z BREATHERS received FDA 510(k) clearance on 1995-12-08, under 510(k) number K953042.

Who is the listed applicant for E-Z BREATHERS?

The FDA 510(k) record lists E-Z Kare Good Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Z BREATHERS?

The FDA product code for E-Z BREATHERS is LWF.

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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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