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FDA 510(k)

MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50

K-Number: K854581 · 1986-02-28

ApplicantMachida America, Inc.
Decision Date1986-02-28
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 is the device name listed in this FDA 510(k) record. The listed applicant is Machida America, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K854581. 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 MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50?

MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Machida America, Inc.. The 510(k) number is K854581.

When did MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 receive FDA 510(k) clearance?

MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 received FDA 510(k) clearance on 1986-02-28, under 510(k) number K854581.

Who is the listed applicant for MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50?

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

What is the FDA product code for MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50?

The FDA product code for MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 is EOQ.

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Other records listing Machida America, 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.

K871712MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.K844834MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1K841087FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000K821182MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-K821181FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #K812734MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P

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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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