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FDA 510(k)

NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)

K-Number: K131873 · 2013-09-25

ApplicantMethodSense, Inc.
Decision Date2013-09-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) is the device name listed in this FDA 510(k) record. The listed applicant is MethodSense, Inc.. It received FDA 510(k) clearance on 2013-09-25 under 510(k) number K131873. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)?

NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) is a medical device that received FDA 510(k) clearance on 2013-09-25. The listed applicant is MethodSense, Inc.. The 510(k) number is K131873.

When did NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) receive FDA 510(k) clearance?

NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) received FDA 510(k) clearance on 2013-09-25, under 510(k) number K131873.

Who is the listed applicant for NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)?

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

What is the FDA product code for NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)?

The FDA product code for NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) is LLZ.

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Related Devices (Code: LLZ)

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

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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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