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FDA 510(k)

FB-18X, FIBER BRONCHOSCOPE

K-Number: K951199 · 1995-04-10

ApplicantPentax Precision Instrument Corp.
Decision Date1995-04-10
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FB-18X, FIBER BRONCHOSCOPE 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 1995-04-10 under 510(k) number K951199. 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 FB-18X, FIBER BRONCHOSCOPE?

FB-18X, FIBER BRONCHOSCOPE is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K951199.

When did FB-18X, FIBER BRONCHOSCOPE receive FDA 510(k) clearance?

FB-18X, FIBER BRONCHOSCOPE received FDA 510(k) clearance on 1995-04-10, under 510(k) number K951199.

Who is the listed applicant for FB-18X, FIBER BRONCHOSCOPE?

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 FB-18X, FIBER BRONCHOSCOPE?

The FDA product code for FB-18X, FIBER BRONCHOSCOPE 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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