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FDA 510(k)

A5 ANESTHESIA DELIVERY SYSTEM

K-Number: K123211 · 2013-02-14

ApplicantDatascope Corp., Patient Monitoring Division
Decision Date2013-02-14
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

A5 ANESTHESIA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp., Patient Monitoring Division. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K123211. 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 A5 ANESTHESIA DELIVERY SYSTEM?

A5 ANESTHESIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Datascope Corp., Patient Monitoring Division. The 510(k) number is K123211.

When did A5 ANESTHESIA DELIVERY SYSTEM receive FDA 510(k) clearance?

A5 ANESTHESIA DELIVERY SYSTEM received FDA 510(k) clearance on 2013-02-14, under 510(k) number K123211.

Who is the listed applicant for A5 ANESTHESIA DELIVERY SYSTEM?

The FDA 510(k) record lists Datascope Corp., Patient Monitoring Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A5 ANESTHESIA DELIVERY SYSTEM?

The FDA product code for A5 ANESTHESIA DELIVERY SYSTEM is BSZ.

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Other records listing Datascope Corp., Patient Monitoring Division as applicant

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.

K091834PASSPORT V MONITOR, MODEL 0998-00-6100K091068ACCUTORR V MONITOR, MODEL 0998-00-2000K080175NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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