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FDA 510(k)

NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB

K-Number: K062131 · 2006-11-17

ApplicantBarcoview
Decision Date2006-11-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K062131. 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 NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB?

NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is Barcoview. The 510(k) number is K062131.

When did NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB receive FDA 510(k) clearance?

NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB received FDA 510(k) clearance on 2006-11-17, under 510(k) number K062131.

Who is the listed applicant for NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB?

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

What is the FDA product code for NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB?

The FDA product code for NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB is LLZ.

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Other records listing Barcoview 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.

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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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