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FDA 510(k)

DIACARE MONITORING SYSTEM

K-Number: K882001 · 1988-10-18

ApplicantHealthware Corp.
Decision Date1988-10-18
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIACARE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthware Corp.. It received FDA 510(k) clearance on 1988-10-18 under 510(k) number K882001. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIACARE MONITORING SYSTEM?

DIACARE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-18. The listed applicant is Healthware Corp.. The 510(k) number is K882001.

When did DIACARE MONITORING SYSTEM receive FDA 510(k) clearance?

DIACARE MONITORING SYSTEM received FDA 510(k) clearance on 1988-10-18, under 510(k) number K882001.

Who is the listed applicant for DIACARE MONITORING SYSTEM?

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

What is the FDA product code for DIACARE MONITORING SYSTEM?

The FDA product code for DIACARE MONITORING SYSTEM is NDC.

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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.

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