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FDA 510(k)

IMAGICA MICRO-ENDOSCOPE

K-Number: K921393 · 1992-08-20

ApplicantFiberoptic Medical Products, Inc.
Decision Date1992-08-20
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMAGICA MICRO-ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Medical Products, Inc.. It received FDA 510(k) clearance on 1992-08-20 under 510(k) number K921393. 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 IMAGICA MICRO-ENDOSCOPE?

IMAGICA MICRO-ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1992-08-20. The listed applicant is Fiberoptic Medical Products, Inc.. The 510(k) number is K921393.

When did IMAGICA MICRO-ENDOSCOPE receive FDA 510(k) clearance?

IMAGICA MICRO-ENDOSCOPE received FDA 510(k) clearance on 1992-08-20, under 510(k) number K921393.

Who is the listed applicant for IMAGICA MICRO-ENDOSCOPE?

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

What is the FDA product code for IMAGICA MICRO-ENDOSCOPE?

The FDA product code for IMAGICA MICRO-ENDOSCOPE is EOQ.

Related Clinical Trials

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.

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Other records listing Fiberoptic Medical Products, 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.

K944686FIBEROPTIC LARYNGOSCOPE HANDLEK933598ENDOSTAR(TM) STYLETK912252INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHTK883779WALLABY(TM) BLANKET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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