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FDA 510(k)

MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2

K-Number: K060193 · 2006-04-10

ApplicantOceanic Medical Products, Inc.
Decision Date2006-04-10
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Oceanic Medical Products, Inc.. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K060193. 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 MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2?

MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Oceanic Medical Products, Inc.. The 510(k) number is K060193.

When did MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 receive FDA 510(k) clearance?

MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 received FDA 510(k) clearance on 2006-04-10, under 510(k) number K060193.

Who is the listed applicant for MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2?

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

What is the FDA product code for MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2?

The FDA product code for MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 is BSZ.

Related Clinical Trials

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.

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Other records listing Oceanic Medical Products, 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.

K072420MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINEK010613MAGELLAN-2200, MODEL 1K002951MAGELLAN VENTILATOR

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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