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FDA 510(k)

RESPIFIT S, MODEL RS-LR1001004

K-Number: K080299 · 2009-01-13

ApplicantEumedics Medizintechnik Und Marketing GmbH
Decision Date2009-01-13
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIFIT S, MODEL RS-LR1001004 is the device name listed in this FDA 510(k) record. The listed applicant is Eumedics Medizintechnik Und Marketing GmbH. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K080299. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIFIT S, MODEL RS-LR1001004?

RESPIFIT S, MODEL RS-LR1001004 is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is Eumedics Medizintechnik Und Marketing GmbH. The 510(k) number is K080299.

When did RESPIFIT S, MODEL RS-LR1001004 receive FDA 510(k) clearance?

RESPIFIT S, MODEL RS-LR1001004 received FDA 510(k) clearance on 2009-01-13, under 510(k) number K080299.

Who is the listed applicant for RESPIFIT S, MODEL RS-LR1001004?

The FDA 510(k) record lists Eumedics Medizintechnik Und Marketing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIFIT S, MODEL RS-LR1001004?

The FDA product code for RESPIFIT S, MODEL RS-LR1001004 is BWF.

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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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