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FDA 510(k)

TRIOS 02

K-Number: K905087 · 1991-05-07

ApplicantBiotronik, GmbH & Co.
Decision Date1991-05-07
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIOS 02 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 1991-05-07 under 510(k) number K905087. 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 TRIOS 02?

TRIOS 02 is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K905087.

When did TRIOS 02 receive FDA 510(k) clearance?

TRIOS 02 received FDA 510(k) clearance on 1991-05-07, under 510(k) number K905087.

Who is the listed applicant for TRIOS 02?

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 TRIOS 02?

The FDA product code for TRIOS 02 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 MONITORK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

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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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