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FDA 510(k)

VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH

K-Number: K963795 · 1996-12-23

ApplicantVision-Sciences, Inc.
Decision Date1996-12-23
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Vision-Sciences, Inc.. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K963795. 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 VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH?

VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K963795.

When did VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH receive FDA 510(k) clearance?

VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH received FDA 510(k) clearance on 1996-12-23, under 510(k) number K963795.

Who is the listed applicant for VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH?

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

What is the FDA product code for VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH?

The FDA product code for VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH is EOQ.

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Other records listing Vision-Sciences, Inc. as applicant

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Related Devices (Code: EOQ)

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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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