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FDA 510(k)

ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK

K-Number: K081518 · 2008-09-05

ApplicantPentax Medical Company
Decision Date2008-09-05
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical Company. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081518. 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 ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK?

ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Pentax Medical Company. The 510(k) number is K081518.

When did ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK receive FDA 510(k) clearance?

ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081518.

Who is the listed applicant for ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK?

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

What is the FDA product code for ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK?

The FDA product code for ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK is EOQ.

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Other records listing Pentax Medical Company 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.

K093037PENTEX EC-3890LIK092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEK090196EG-3670URKK090197EG-3870UTKK061068EG-3670URKK042740ISC-1000 PENTAX CONFOCAL LASER SYSTEM

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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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