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FDA 510(k)

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH

K-Number: K221781 · 2023-02-02

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2023-02-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K221781. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221781.

When did Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH receive FDA 510(k) clearance?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH received FDA 510(k) clearance on 2023-02-02, under 510(k) number K221781.

Who is the listed applicant for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

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

What is the FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

The FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is GCJ.

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Other records listing Guangdong Optomedic Technologies, 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.

K252318Insufflator (OPTO-IFL1000)K2526973D LaparoscopeK242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging SystemK231342Insufflator (OPTO-IFL1000)K230407FloNavi Open Field Fluorescence Imaging System

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Related Devices (Code: GCJ)

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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Official Source

View on FDA Database →

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