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FDA 510(k)

CASE 8000 EXERCISE TESTING SYSTEM

K-Number: K991014 · 1999-10-20

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date1999-10-20
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CASE 8000 EXERCISE TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 1999-10-20 under 510(k) number K991014. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASE 8000 EXERCISE TESTING SYSTEM?

CASE 8000 EXERCISE TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-20. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K991014.

When did CASE 8000 EXERCISE TESTING SYSTEM receive FDA 510(k) clearance?

CASE 8000 EXERCISE TESTING SYSTEM received FDA 510(k) clearance on 1999-10-20, under 510(k) number K991014.

Who is the listed applicant for CASE 8000 EXERCISE TESTING SYSTEM?

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

What is the FDA product code for CASE 8000 EXERCISE TESTING SYSTEM?

The FDA product code for CASE 8000 EXERCISE TESTING SYSTEM is LOS.

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Other records listing General Electric Medical Systems Information Techn as applicant

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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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