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FDA 510(k)

CRIT-LINE

K-Number: K924167 · 1993-05-07

ApplicantNoninvasive Medical Technology Corp.
Decision Date1993-05-07
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE is the device name listed in this FDA 510(k) record. The listed applicant is Noninvasive Medical Technology Corp.. It received FDA 510(k) clearance on 1993-05-07 under 510(k) number K924167. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRIT-LINE?

CRIT-LINE is a medical device that received FDA 510(k) clearance on 1993-05-07. The listed applicant is Noninvasive Medical Technology Corp.. The 510(k) number is K924167.

When did CRIT-LINE receive FDA 510(k) clearance?

CRIT-LINE received FDA 510(k) clearance on 1993-05-07, under 510(k) number K924167.

Who is the listed applicant for CRIT-LINE?

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

What is the FDA product code for CRIT-LINE?

The FDA product code for CRIT-LINE is JPI.

Other records listing Noninvasive Medical Technology Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910077CRIT-SCAN

Related Devices (Code: JPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott LaboratoriesK950942CRIT-LINE HEMATOCRIT ALERTIn-Line Diagnostics Corp.K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin TechnologiesK902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, Inc.K870511CHART-TYPE MICRO HEMATOCRIT TUBE READERNorfolk Scientific, Inc.

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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