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FDA 510(k)

FLEXISCOPE, MODELS 50MH AND 50 MHC

K-Number: K053412 · 2006-02-23

ApplicantSchoelly Imaging, Inc.
Decision Date2006-02-23
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLEXISCOPE, MODELS 50MH AND 50 MHC is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Imaging, Inc.. It received FDA 510(k) clearance on 2006-02-23 under 510(k) number K053412. The device is classified under product code FWF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXISCOPE, MODELS 50MH AND 50 MHC?

FLEXISCOPE, MODELS 50MH AND 50 MHC is a medical device that received FDA 510(k) clearance on 2006-02-23. The listed applicant is Schoelly Imaging, Inc.. The 510(k) number is K053412.

When did FLEXISCOPE, MODELS 50MH AND 50 MHC receive FDA 510(k) clearance?

FLEXISCOPE, MODELS 50MH AND 50 MHC received FDA 510(k) clearance on 2006-02-23, under 510(k) number K053412.

Who is the listed applicant for FLEXISCOPE, MODELS 50MH AND 50 MHC?

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

What is the FDA product code for FLEXISCOPE, MODELS 50MH AND 50 MHC?

The FDA product code for FLEXISCOPE, MODELS 50MH AND 50 MHC is FWF.

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Other records listing Schoelly Imaging, 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.

K090800VS-100 ILLUMINATION AND IMAGING SYSTEMK090601FSC 2K083553NASO-LARYNGO-PHARYNGOSCOPEK060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE

Related Devices (Code: FWF)

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.

K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.K982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs ConsultingK982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.K982409VES 1501-MAngiolaz, Inc.K981819ANGIOLAZ VES-1CAMAngiolaz, Inc.

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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