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FDA 510(k)

CRIT-SCAN II MONITOR

K-Number: K983551 · 1999-05-27

ApplicantIn-Line Diagnostics Corp.
Decision Date1999-05-27
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRIT-SCAN II MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is In-Line Diagnostics Corp.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K983551. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRIT-SCAN II MONITOR?

CRIT-SCAN II MONITOR is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is In-Line Diagnostics Corp.. The 510(k) number is K983551.

When did CRIT-SCAN II MONITOR receive FDA 510(k) clearance?

CRIT-SCAN II MONITOR received FDA 510(k) clearance on 1999-05-27, under 510(k) number K983551.

Who is the listed applicant for CRIT-SCAN II MONITOR?

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

What is the FDA product code for CRIT-SCAN II MONITOR?

The FDA product code for CRIT-SCAN II MONITOR is GKF.

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Other records listing In-Line Diagnostics 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.

K001763CRIT-LINE MONITOR III (CLM III)K992227CRIT-LINE MONITOR III (CLM III)K982412MODIFICATION OF CRIT-LINE MONITOR III (CLM III)K972470CRIT-LINE MONITOR (CLMIII)K953875CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)K950942CRIT-LINE HEMATOCRIT ALERT

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Related Devices (Code: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K953519MICROSPIN 24Vulcon TechnologiesK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEFisher Scientific Co., LLC

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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