FDA 510(k)

STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+

K-Number: K061830 · 2006-11-01

Decision Date2006-11-01

Product CodeCIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 2006-11-01 under 510(k) number K061830. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+?

STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ is a medical device that received FDA 510(k) clearance on 2006-11-01. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K061830.

When did STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ receive FDA 510(k) clearance?

STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ received FDA 510(k) clearance on 2006-11-01, under 510(k) number K061830.

Who is the listed applicant for STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+?

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

What is the FDA product code for STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+?

The FDA product code for STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ is CIG.

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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.