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FDA 510(k)

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

K-Number: K190512 · 2019-11-22

ApplicantIntelligent Endoscopy
Decision Date2019-11-22
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Endoscopy. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K190512. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Intelligent Endoscopy. The 510(k) number is K190512.

When did SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare receive FDA 510(k) clearance?

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare received FDA 510(k) clearance on 2019-11-22, under 510(k) number K190512.

Who is the listed applicant for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

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

What is the FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

The FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is FDI.

Related Devices (Code: FDI)

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 →

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

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