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FDA 510(k)

PIKOS 01 & PIKOS E 01

K-Number: K914109 · 1992-02-26

ApplicantBiotronik, GmbH & Co.
Decision Date1992-02-26
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PIKOS 01 & PIKOS E 01 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1992-02-26 under 510(k) number K914109. 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.

Frequently Asked Questions

What is the PIKOS 01 & PIKOS E 01?

PIKOS 01 & PIKOS E 01 is a medical device that received FDA 510(k) clearance on 1992-02-26. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K914109.

When did PIKOS 01 & PIKOS E 01 receive FDA 510(k) clearance?

PIKOS 01 & PIKOS E 01 received FDA 510(k) clearance on 1992-02-26, under 510(k) number K914109.

Who is the listed applicant for PIKOS 01 & PIKOS E 01?

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

What is the FDA product code for PIKOS 01 & PIKOS E 01?

The FDA product code for PIKOS 01 & PIKOS E 01 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Biotronik, GmbH & Co. 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.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERK922742HPM 40 HEART PACEMAKER MONITORK910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIPK911142LEAD TERMINAL PIN CAPS, VARIOUS MODELS

View all 18 devices →

Related Devices (Code: DXY)

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.

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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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