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FDA 510(k)

OPTUS LARYNGOSCOPES

K-Number: K945269 · 1994-11-07

ApplicantOptus, Inc.
Decision Date1994-11-07
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTUS LARYNGOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K945269. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTUS LARYNGOSCOPES?

OPTUS LARYNGOSCOPES is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Optus, Inc.. The 510(k) number is K945269.

When did OPTUS LARYNGOSCOPES receive FDA 510(k) clearance?

OPTUS LARYNGOSCOPES received FDA 510(k) clearance on 1994-11-07, under 510(k) number K945269.

Who is the listed applicant for OPTUS LARYNGOSCOPES?

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

What is the FDA product code for OPTUS LARYNGOSCOPES?

The FDA product code for OPTUS LARYNGOSCOPES is CCW.

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Other records listing Optus, 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.

K945264OPTUS OTOSCOPESK953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

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Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLCK062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, 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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