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FDA 510(k)

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

K-Number: K102618 · 2010-12-10

ApplicantDraeger Medical AG & Co. KG
Decision Date2010-12-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED 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 2010-12-10 under 510(k) number K102618. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED?

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Draeger Medical AG & Co. KG. The 510(k) number is K102618.

When did VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED receive FDA 510(k) clearance?

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED received FDA 510(k) clearance on 2010-12-10, under 510(k) number K102618.

Who is the listed applicant for VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED?

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 VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED?

The FDA product code for VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED is BTT.

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Other records listing Draeger Medical AG & Co. KG as applicant

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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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