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FDA 510(k)

ORLOCATE SYSTEM MODEL ORL 100

K-Number: K100551 · 2010-08-12

ApplicantHaldor Advanced Technologies, Ltd.
Decision Date2010-08-12
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ORLOCATE SYSTEM MODEL ORL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Haldor Advanced Technologies, Ltd.. It received FDA 510(k) clearance on 2010-08-12 under 510(k) number K100551. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORLOCATE SYSTEM MODEL ORL 100?

ORLOCATE SYSTEM MODEL ORL 100 is a medical device that received FDA 510(k) clearance on 2010-08-12. The listed applicant is Haldor Advanced Technologies, Ltd.. The 510(k) number is K100551.

When did ORLOCATE SYSTEM MODEL ORL 100 receive FDA 510(k) clearance?

ORLOCATE SYSTEM MODEL ORL 100 received FDA 510(k) clearance on 2010-08-12, under 510(k) number K100551.

Who is the listed applicant for ORLOCATE SYSTEM MODEL ORL 100?

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

What is the FDA product code for ORLOCATE SYSTEM MODEL ORL 100?

The FDA product code for ORLOCATE SYSTEM MODEL ORL 100 is LWH.

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Related Devices (Code: LWH)

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.

K121274PIXEL APPGauss Surgical, Inc.,K120473PIXEL APPGauss Surgical, Inc.,K093557SMARTWAND-DTXClearcount Medical SolutionsK073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, Inc.K062642RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100ARf Surgical Systems, Inc.

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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