FDA 510(k)

NKA MODEL SEC-3102 CARDIAC STIMULATOR

K-Number: K894492 · 1989-12-20

Decision Date1989-12-20

Product CodeDRO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NKA MODEL SEC-3102 CARDIAC STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1989-12-20 under 510(k) number K894492. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NKA MODEL SEC-3102 CARDIAC STIMULATOR?

NKA MODEL SEC-3102 CARDIAC STIMULATOR is a medical device that received FDA 510(k) clearance on 1989-12-20. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K894492.

When did NKA MODEL SEC-3102 CARDIAC STIMULATOR receive FDA 510(k) clearance?

NKA MODEL SEC-3102 CARDIAC STIMULATOR received FDA 510(k) clearance on 1989-12-20, under 510(k) number K894492.

Who is the listed applicant for NKA MODEL SEC-3102 CARDIAC STIMULATOR?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NKA MODEL SEC-3102 CARDIAC STIMULATOR?

The FDA product code for NKA MODEL SEC-3102 CARDIAC STIMULATOR is DRO.

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Related Devices (Code: DRO)

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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.