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FDA 510(k)

BRONCHO FIBERSCOPE FB-19C

K-Number: K832492 · 1983-09-20

ApplicantPentax Precision Instrument Corp.
Decision Date1983-09-20
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BRONCHO FIBERSCOPE FB-19C is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832492. 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 BRONCHO FIBERSCOPE FB-19C?

BRONCHO FIBERSCOPE FB-19C is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K832492.

When did BRONCHO FIBERSCOPE FB-19C receive FDA 510(k) clearance?

BRONCHO FIBERSCOPE FB-19C received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832492.

Who is the listed applicant for BRONCHO FIBERSCOPE FB-19C?

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

What is the FDA product code for BRONCHO FIBERSCOPE FB-19C?

The FDA product code for BRONCHO FIBERSCOPE FB-19C is EOQ.

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Other records listing Pentax Precision Instrument Corp. 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.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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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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