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FDA 510(k)

ENDOSCOUT TRACKING SYSTEM

K-Number: K111226 · 2011-07-01

ApplicantRobin Medical, Inc.
Decision Date2011-07-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENDOSCOUT TRACKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Robin Medical, Inc.. It received FDA 510(k) clearance on 2011-07-01 under 510(k) number K111226. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOUT TRACKING SYSTEM?

ENDOSCOUT TRACKING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is Robin Medical, Inc.. The 510(k) number is K111226.

When did ENDOSCOUT TRACKING SYSTEM receive FDA 510(k) clearance?

ENDOSCOUT TRACKING SYSTEM received FDA 510(k) clearance on 2011-07-01, under 510(k) number K111226.

Who is the listed applicant for ENDOSCOUT TRACKING SYSTEM?

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

What is the FDA product code for ENDOSCOUT TRACKING SYSTEM?

The FDA product code for ENDOSCOUT TRACKING SYSTEM is LNH.

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 Robin 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.

K033485ENDOSCOUT

Related Devices (Code: LNH)

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.

K261283APERTO Lucent MRI SystemFujifilm CorporationK261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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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