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FDA 510(k)

REFLEX HTR

K-Number: K931879 · 1994-03-24

ApplicantRichard-Allan Medical Ind., Inc.
Decision Date1994-03-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REFLEX HTR is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical Ind., Inc.. It received FDA 510(k) clearance on 1994-03-24 under 510(k) number K931879. 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 REFLEX HTR?

REFLEX HTR is a medical device that received FDA 510(k) clearance on 1994-03-24. The listed applicant is Richard-Allan Medical Ind., Inc.. The 510(k) number is K931879.

When did REFLEX HTR receive FDA 510(k) clearance?

REFLEX HTR received FDA 510(k) clearance on 1994-03-24, under 510(k) number K931879.

Who is the listed applicant for REFLEX HTR?

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

What is the FDA product code for REFLEX HTR?

The FDA product code for REFLEX HTR is GCJ.

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Other records listing Richard-Allan Medical Ind., 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.

K924200REFLEX(R) ESCK926297REFLEX ESIK924761STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELDK900566RICHARD-ALLAN VESSEL LOOPSK896262TITANIUM LIGATING CLIPSK890314PROTECTOR (SURGICAL INSTRUMENT)

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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