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FDA 510(k)

Aisys CS2

K-Number: K170872 · 2017-08-15

ApplicantDatex-Ohmeda, Inc.
Decision Date2017-08-15
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aisys CS2 is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K170872. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aisys CS2?

Aisys CS2 is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K170872.

When did Aisys CS2 receive FDA 510(k) clearance?

Aisys CS2 received FDA 510(k) clearance on 2017-08-15, under 510(k) number K170872.

Who is the listed applicant for Aisys CS2?

The FDA 510(k) record lists Datex-Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aisys CS2?

The FDA product code for Aisys CS2 is BSZ.

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Related Devices (Code: BSZ)

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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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