FDA 510(k)

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.

K-Number: K811350 · 1981-07-01

Decision Date1981-07-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811350. 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 UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.?

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Medtronic Vascular. The 510(k) number is K811350.

When did UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. receive FDA 510(k) clearance?

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811350.

Who is the listed applicant for UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.?

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

What is the FDA product code for UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.?

The FDA product code for UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.