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FDA 510(k)

BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000

K-Number: K041430 · 2004-10-07

ApplicantBlease Medical Equipment , Ltd.
Decision Date2004-10-07
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Blease Medical Equipment , Ltd.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K041430. 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 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000?

BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Blease Medical Equipment , Ltd.. The 510(k) number is K041430.

When did BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 receive FDA 510(k) clearance?

BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 received FDA 510(k) clearance on 2004-10-07, under 510(k) number K041430.

Who is the listed applicant for BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000?

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

What is the FDA product code for BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000?

The FDA product code for BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 is BSZ.

Related Clinical Trials

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Other records listing Blease Medical Equipment , Ltd. 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.

K003251BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690K001727MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINESK982132BLEASE 6200 ANAESTHESIA VENTILATORK982137BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE

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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