FDA 510(k)

CRITICAL CARE ASSESSMENT

K-Number: K101983 · 2010-09-21

Decision Date2010-09-21

Product CodeJOM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CRITICAL CARE ASSESSMENT is the device name listed in this FDA 510(k) record. The listed applicant is Critical Patient Care, Inc.. It received FDA 510(k) clearance on 2010-09-21 under 510(k) number K101983. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITICAL CARE ASSESSMENT?

CRITICAL CARE ASSESSMENT is a medical device that received FDA 510(k) clearance on 2010-09-21. The listed applicant is Critical Patient Care, Inc.. The 510(k) number is K101983.

When did CRITICAL CARE ASSESSMENT receive FDA 510(k) clearance?

CRITICAL CARE ASSESSMENT received FDA 510(k) clearance on 2010-09-21, under 510(k) number K101983.

Who is the listed applicant for CRITICAL CARE ASSESSMENT?

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

What is the FDA product code for CRITICAL CARE ASSESSMENT?

The FDA product code for CRITICAL CARE ASSESSMENT is JOM.

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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.