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FDA 510(k)

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

K-Number: K071473 · 2007-07-12

ApplicantSuperdimension, Ltd.
Decision Date2007-07-12
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Ltd.. It received FDA 510(k) clearance on 2007-07-12 under 510(k) number K071473. 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 MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2?

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 is a medical device that received FDA 510(k) clearance on 2007-07-12. The listed applicant is Superdimension, Ltd.. The 510(k) number is K071473.

When did MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 receive FDA 510(k) clearance?

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 received FDA 510(k) clearance on 2007-07-12, under 510(k) number K071473.

Who is the listed applicant for MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2?

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

What is the FDA product code for MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2?

The FDA product code for MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 is EOQ.

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Other records listing Superdimension, Ltd. 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.

K102604I-LOGIC INREACH SYSTEMK092365INREACH SYSTEM, MODEL AAS00161-02K082386INREACH PLANNING LAPTOPK081379MODIFICATION TO INREACH SYSTEMK080271INREACH SYSTEMK062315SUPERDIMENSION/BRONCHUS PREMIUM 2

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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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