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FDA 510(k)

SAFE TEE

K-Number: K955076 · 1996-04-02

ApplicantPearson Strach Medical
Decision Date1996-04-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SAFE TEE is the device name listed in this FDA 510(k) record. The listed applicant is Pearson Strach Medical. It received FDA 510(k) clearance on 1996-04-02 under 510(k) number K955076. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE TEE?

SAFE TEE is a medical device that received FDA 510(k) clearance on 1996-04-02. The listed applicant is Pearson Strach Medical. The 510(k) number is K955076.

When did SAFE TEE receive FDA 510(k) clearance?

SAFE TEE received FDA 510(k) clearance on 1996-04-02, under 510(k) number K955076.

Who is the listed applicant for SAFE TEE?

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

What is the FDA product code for SAFE TEE?

The FDA product code for SAFE TEE is GCJ.

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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