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FDA 510(k)

NETLINK/NETSCAN

K-Number: K020213 · 2002-04-05

ApplicantRozinn Electronics, Inc.
Decision Date2002-04-05
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NETLINK/NETSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Rozinn Electronics, Inc.. It received FDA 510(k) clearance on 2002-04-05 under 510(k) number K020213. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NETLINK/NETSCAN?

NETLINK/NETSCAN is a medical device that received FDA 510(k) clearance on 2002-04-05. The listed applicant is Rozinn Electronics, Inc.. The 510(k) number is K020213.

When did NETLINK/NETSCAN receive FDA 510(k) clearance?

NETLINK/NETSCAN received FDA 510(k) clearance on 2002-04-05, under 510(k) number K020213.

Who is the listed applicant for NETLINK/NETSCAN?

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

What is the FDA product code for NETLINK/NETSCAN?

The FDA product code for NETLINK/NETSCAN is DXH. This falls under the Hematology category.

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Other records listing Rozinn Electronics, 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.

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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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