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FDA 510(k)

BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000

K-Number: K051629 · 2005-09-23

ApplicantBlease USA, Inc.
Decision Date2005-09-23
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Blease USA, Inc.. It received FDA 510(k) clearance on 2005-09-23 under 510(k) number K051629. 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 BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000?

BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 is a medical device that received FDA 510(k) clearance on 2005-09-23. The listed applicant is Blease USA, Inc.. The 510(k) number is K051629.

When did BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 receive FDA 510(k) clearance?

BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 received FDA 510(k) clearance on 2005-09-23, under 510(k) number K051629.

Who is the listed applicant for BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000?

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

What is the FDA product code for BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000?

The FDA product code for BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 is BSZ.

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Other records listing Blease USA, Inc. 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.

K942799DATUM

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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