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FDA 510(k)

LITHIUM PACEMAKER 811-811L & 811XL

K-Number: K840748 · 1984-08-03

ApplicantOmikron Scientific, Ltd.
Decision Date1984-08-03
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LITHIUM PACEMAKER 811-811L & 811XL is the device name listed in this FDA 510(k) record. The listed applicant is Omikron Scientific, Ltd.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K840748. 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 LITHIUM PACEMAKER 811-811L & 811XL?

LITHIUM PACEMAKER 811-811L & 811XL is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Omikron Scientific, Ltd.. The 510(k) number is K840748.

When did LITHIUM PACEMAKER 811-811L & 811XL receive FDA 510(k) clearance?

LITHIUM PACEMAKER 811-811L & 811XL received FDA 510(k) clearance on 1984-08-03, under 510(k) number K840748.

Who is the listed applicant for LITHIUM PACEMAKER 811-811L & 811XL?

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

What is the FDA product code for LITHIUM PACEMAKER 811-811L & 811XL?

The FDA product code for LITHIUM PACEMAKER 811-811L & 811XL is DXY. This falls under the Clinical Chemistry category.

Related Clinical Trials

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Other records listing Omikron Scientific, Ltd. 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.

K904445OMIBANDK874480MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)K844277OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR

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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