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FDA 510(k)

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55

K-Number: K072002 · 2008-01-31

ApplicantDraeger Medical AG & Co. KG
Decision Date2008-01-31
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical AG & Co. KG. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K072002. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55?

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Draeger Medical AG & Co. KG. The 510(k) number is K072002.

When did FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 receive FDA 510(k) clearance?

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 received FDA 510(k) clearance on 2008-01-31, under 510(k) number K072002.

Who is the listed applicant for FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55?

The FDA 510(k) record lists Draeger Medical AG & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55?

The FDA product code for FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 is CAH.

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Official Source

View on FDA Database →

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

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