FDA 510(k)

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

K-Number: K010093 · 2001-06-14

Decision Date2001-06-14

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medizintechnik GmbH. It received FDA 510(k) clearance on 2001-06-14 under 510(k) number K010093. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474?

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 is a medical device that received FDA 510(k) clearance on 2001-06-14. The listed applicant is Drager Medizintechnik GmbH. The 510(k) number is K010093.

When did NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 receive FDA 510(k) clearance?

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 received FDA 510(k) clearance on 2001-06-14, under 510(k) number K010093.

Who is the listed applicant for NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474?

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

What is the FDA product code for NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474?

The FDA product code for NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 is CBK.

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Related Devices (Code: CBK)

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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.