FDA 510(k)

2D CARDIAC SECTOR SCANNER

K-Number: K837097 · 1983-03-22

Decision Date1983-03-22

Product Code

DecisionSubstantially Equivalent

Device Summary

2D CARDIAC SECTOR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Second Foundation, Inc.. It received FDA 510(k) clearance on 1983-03-22 under 510(k) number K837097. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2D CARDIAC SECTOR SCANNER?

2D CARDIAC SECTOR SCANNER is a medical device that received FDA 510(k) clearance on 1983-03-22. The listed applicant is Second Foundation, Inc.. The 510(k) number is K837097.

When did 2D CARDIAC SECTOR SCANNER receive FDA 510(k) clearance?

2D CARDIAC SECTOR SCANNER received FDA 510(k) clearance on 1983-03-22, under 510(k) number K837097.

Who is the listed applicant for 2D CARDIAC SECTOR SCANNER?

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

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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.