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FDA 510(k)

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF

K-Number: K810751 · 1981-04-10

ApplicantGeneral Electric Co.
Decision Date1981-04-10
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1981-04-10 under 510(k) number K810751. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF?

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF is a medical device that received FDA 510(k) clearance on 1981-04-10. The listed applicant is General Electric Co.. The 510(k) number is K810751.

When did PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF receive FDA 510(k) clearance?

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF received FDA 510(k) clearance on 1981-04-10, under 510(k) number K810751.

Who is the listed applicant for PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF?

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

What is the FDA product code for PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF?

The FDA product code for PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF is BZC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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