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FDA 510(k)

AESPIRE 7900, AESPIRE VIEW

K-Number: K122445 · 2012-10-12

ApplicantDatex-Ohmeda
Decision Date2012-10-12
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AESPIRE 7900, AESPIRE VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K122445. 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 AESPIRE 7900, AESPIRE VIEW?

AESPIRE 7900, AESPIRE VIEW is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Datex-Ohmeda. The 510(k) number is K122445.

When did AESPIRE 7900, AESPIRE VIEW receive FDA 510(k) clearance?

AESPIRE 7900, AESPIRE VIEW received FDA 510(k) clearance on 2012-10-12, under 510(k) number K122445.

Who is the listed applicant for AESPIRE 7900, AESPIRE VIEW?

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

What is the FDA product code for AESPIRE 7900, AESPIRE VIEW?

The FDA product code for AESPIRE 7900, AESPIRE VIEW is BSZ.

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Related Devices (Code: BSZ)

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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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