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FDA 510(k)

BOYLE SYSTEM ANESTHESIA GAS MACHINE

K-Number: K833151 · 1983-11-14

ApplicantFraser Harlake, Inc.
Decision Date1983-11-14
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BOYLE SYSTEM ANESTHESIA GAS MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Fraser Harlake, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K833151. 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 BOYLE SYSTEM ANESTHESIA GAS MACHINE?

BOYLE SYSTEM ANESTHESIA GAS MACHINE is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Fraser Harlake, Inc.. The 510(k) number is K833151.

When did BOYLE SYSTEM ANESTHESIA GAS MACHINE receive FDA 510(k) clearance?

BOYLE SYSTEM ANESTHESIA GAS MACHINE received FDA 510(k) clearance on 1983-11-14, under 510(k) number K833151.

Who is the listed applicant for BOYLE SYSTEM ANESTHESIA GAS MACHINE?

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

What is the FDA product code for BOYLE SYSTEM ANESTHESIA GAS MACHINE?

The FDA product code for BOYLE SYSTEM ANESTHESIA GAS MACHINE is BSZ.

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Other records listing Fraser Harlake, 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.

K841903FRASER HARLAKE EMERG. CARE SUCTION SYSK833799SPHYGOMANO METERK841496FRASER HARLAKE HOPE III RESUSCITATORK833692FRASER HARLAKE DENTAL ANTI-POLUTION SYSK831427CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.K822040POWERED EMERGENCY VENTILATOR

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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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