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FDA 510(k)

SABRE COMPAC

K-Number: K011842 · 2002-01-08

ApplicantSle Limited
Decision Date2002-01-08
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SABRE COMPAC is the device name listed in this FDA 510(k) record. The listed applicant is Sle Limited. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K011842. 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 COMPAC?

SABRE COMPAC is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Sle Limited. The 510(k) number is K011842.

When did SABRE COMPAC receive FDA 510(k) clearance?

SABRE COMPAC received FDA 510(k) clearance on 2002-01-08, under 510(k) number K011842.

Who is the listed applicant for SABRE COMPAC?

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 COMPAC?

The FDA product code for SABRE COMPAC 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.

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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.

K993177SABRE

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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