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FDA 510(k)

NEOS 02

K-Number: K894240 · 1989-10-26

ApplicantBiotronik Cardiac Pacemakers
Decision Date1989-10-26
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEOS 02 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik Cardiac Pacemakers. It received FDA 510(k) clearance on 1989-10-26 under 510(k) number K894240. 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 NEOS 02?

NEOS 02 is a medical device that received FDA 510(k) clearance on 1989-10-26. The listed applicant is Biotronik Cardiac Pacemakers. The 510(k) number is K894240.

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

NEOS 02 received FDA 510(k) clearance on 1989-10-26, under 510(k) number K894240.

Who is the listed applicant for NEOS 02?

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

What is the FDA product code for NEOS 02?

The FDA product code for NEOS 02 is DXY. This falls under the Clinical Chemistry category.

Other records listing Biotronik Cardiac Pacemakers 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.

K896184KALOS 05 PULSE GENERATORK894239NANOS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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