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FDA 510(k)

FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

K-Number: K011404 · 2002-02-22

ApplicantDraeger Medical, Inc.
Decision Date2002-02-22
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K011404. 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 FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS?

FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K011404.

When did FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS receive FDA 510(k) clearance?

FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS received FDA 510(k) clearance on 2002-02-22, under 510(k) number K011404.

Who is the listed applicant for FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS?

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

What is the FDA product code for FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS?

The FDA product code for FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS is BSZ.

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Other records listing Draeger Medical, 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.

K042607PRIMUS USK042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMK042276D-VAPORK042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

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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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