FDA 510(k)

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01

K-Number: K952328 · 1995-09-29

Decision Date1995-09-29

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K952328. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01?

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Biotronik, Inc.. The 510(k) number is K952328.

When did NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 receive FDA 510(k) clearance?

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 received FDA 510(k) clearance on 1995-09-29, under 510(k) number K952328.

Who is the listed applicant for NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01?

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

What is the FDA product code for NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01?

The FDA product code for NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.