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FDA 510(k)

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

K-Number: K101286 · 2011-10-20

ApplicantLinde Healthcare AB
Decision Date2011-10-20
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 is the device name listed in this FDA 510(k) record. The listed applicant is Linde Healthcare AB. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K101286. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04?

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Linde Healthcare AB. The 510(k) number is K101286.

When did SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 receive FDA 510(k) clearance?

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 received FDA 510(k) clearance on 2011-10-20, under 510(k) number K101286.

Who is the listed applicant for SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04?

The FDA 510(k) record lists Linde Healthcare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04?

The FDA product code for SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 is BZR.

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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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