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FDA 510(k)

MODEL FBS-1, FLEXIBLE BRONCHOSCOPE

K-Number: K811181 · 1981-05-13

ApplicantAmerican Optical Corp.
Decision Date1981-05-13
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL FBS-1, FLEXIBLE BRONCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K811181. 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 MODEL FBS-1, FLEXIBLE BRONCHOSCOPE?

MODEL FBS-1, FLEXIBLE BRONCHOSCOPE is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is American Optical Corp.. The 510(k) number is K811181.

When did MODEL FBS-1, FLEXIBLE BRONCHOSCOPE receive FDA 510(k) clearance?

MODEL FBS-1, FLEXIBLE BRONCHOSCOPE received FDA 510(k) clearance on 1981-05-13, under 510(k) number K811181.

Who is the listed applicant for MODEL FBS-1, FLEXIBLE BRONCHOSCOPE?

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

What is the FDA product code for MODEL FBS-1, FLEXIBLE BRONCHOSCOPE?

The FDA product code for MODEL FBS-1, FLEXIBLE BRONCHOSCOPE is EOQ.

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Other records listing American Optical 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.

K950881PHACO TIPK950880AOI UNIVERSAL ULTRASONIC HANDPIECEK931354P4000 PHACOEMULSIFIERK931358AORP4000 REUSABLE PAKK931357AOD4000 DISPOSABLE PAKK820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

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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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