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FDA 510(k)

AM-6000 ANESTHESIA MACHINE

K-Number: K120075 · 2012-01-26

ApplicantAdvanced Instrumentations, Inc.
Decision Date2012-01-26
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AM-6000 ANESTHESIA MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K120075. 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 AM-6000 ANESTHESIA MACHINE?

AM-6000 ANESTHESIA MACHINE is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K120075.

When did AM-6000 ANESTHESIA MACHINE receive FDA 510(k) clearance?

AM-6000 ANESTHESIA MACHINE received FDA 510(k) clearance on 2012-01-26, under 510(k) number K120075.

Who is the listed applicant for AM-6000 ANESTHESIA MACHINE?

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

What is the FDA product code for AM-6000 ANESTHESIA MACHINE?

The FDA product code for AM-6000 ANESTHESIA MACHINE is BSZ.

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Other records listing Advanced Instrumentations, 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.

K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemK172055DUS-7000 Digital Color Doppler Ultrasound SystemK132059DIAGNOSTIC ULTRASOUND SYSTEMK123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROK112317FM-9000 PLUS FETAL AND MATERNAL MONITORK112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER

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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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