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FDA 510(k)

SABRE

K-Number: K993177 · 1999-11-16

ApplicantSle Limited
Decision Date1999-11-16
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SABRE is the device name listed in this FDA 510(k) record. The listed applicant is Sle Limited. It received FDA 510(k) clearance on 1999-11-16 under 510(k) number K993177. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABRE?

SABRE is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Sle Limited. The 510(k) number is K993177.

When did SABRE receive FDA 510(k) clearance?

SABRE received FDA 510(k) clearance on 1999-11-16, under 510(k) number K993177.

Who is the listed applicant for SABRE?

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

What is the FDA product code for SABRE?

The FDA product code for SABRE is GWJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sle Limited 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.

K011842SABRE COMPAC

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing 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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