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FDA 510(k)

OPTUS BRONCHOSCOPES

K-Number: K945268 · 1995-12-21

ApplicantOptus, Inc.
Decision Date1995-12-21
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTUS BRONCHOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K945268. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTUS BRONCHOSCOPES?

OPTUS BRONCHOSCOPES is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Optus, Inc.. The 510(k) number is K945268.

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

OPTUS BRONCHOSCOPES received FDA 510(k) clearance on 1995-12-21, under 510(k) number K945268.

Who is the listed applicant for OPTUS BRONCHOSCOPES?

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 BRONCHOSCOPES?

The FDA product code for OPTUS BRONCHOSCOPES is EOQ.

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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 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 ACCESSORIESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPESK945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

View all 10 devices →

Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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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