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FDA 510(k)

SMARTPILOT VIEW MODEL MK04500

K-Number: K103035 · 2012-03-28

ApplicantDraeger Medical GmbH
Decision Date2012-03-28
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTPILOT VIEW MODEL MK04500 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical GmbH. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K103035. 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 SMARTPILOT VIEW MODEL MK04500?

SMARTPILOT VIEW MODEL MK04500 is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Draeger Medical GmbH. The 510(k) number is K103035.

When did SMARTPILOT VIEW MODEL MK04500 receive FDA 510(k) clearance?

SMARTPILOT VIEW MODEL MK04500 received FDA 510(k) clearance on 2012-03-28, under 510(k) number K103035.

Who is the listed applicant for SMARTPILOT VIEW MODEL MK04500?

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

What is the FDA product code for SMARTPILOT VIEW MODEL MK04500?

The FDA product code for SMARTPILOT VIEW MODEL MK04500 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 Draeger Medical GmbH 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.

K121999GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE

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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