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FDA 510(k)

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)

K-Number: K132530 · 2013-12-20

ApplicantDatex-Ohmeda, Inc.
Decision Date2013-12-20
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) 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 2013-12-20 under 510(k) number K132530. 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 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)?

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K132530.

When did GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) receive FDA 510(k) clearance?

GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132530.

Who is the listed applicant for GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)?

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 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)?

The FDA product code for GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) is BSZ.

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Other records listing Datex-Ohmeda, Inc. as applicant

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Related Devices (Code: BSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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