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FDA 510(k)

OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR

K-Number: K844277 · 1985-02-15

ApplicantOmikron Scientific, Ltd.
Decision Date1985-02-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR 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 1985-02-15 under 510(k) number K844277. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR?

OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR is a medical device that received FDA 510(k) clearance on 1985-02-15. The listed applicant is Omikron Scientific, Ltd.. The 510(k) number is K844277.

When did OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR receive FDA 510(k) clearance?

OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR received FDA 510(k) clearance on 1985-02-15, under 510(k) number K844277.

Who is the listed applicant for OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR?

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 OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR?

The FDA product code for OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR is DXG.

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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)K840748LITHIUM PACEMAKER 811-811L & 811XL

Related Devices (Code: DXG)

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.

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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.

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