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FDA 510(k)

CRIT-LINE MONITOR (CLMIII)

K-Number: K972470 · 1997-12-11

ApplicantIn-Line Diagnostics Corp.
Decision Date1997-12-11
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE MONITOR (CLMIII) 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 1997-12-11 under 510(k) number K972470. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRIT-LINE MONITOR (CLMIII)?

CRIT-LINE MONITOR (CLMIII) is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is In-Line Diagnostics Corp.. The 510(k) number is K972470.

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

CRIT-LINE MONITOR (CLMIII) received FDA 510(k) clearance on 1997-12-11, under 510(k) number K972470.

Who is the listed applicant for CRIT-LINE MONITOR (CLMIII)?

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-LINE MONITOR (CLMIII)?

The FDA product code for CRIT-LINE MONITOR (CLMIII) is MQS.

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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)K983551CRIT-SCAN II MONITORK982412MODIFICATION OF CRIT-LINE MONITOR III (CLM III)K953875CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)K950942CRIT-LINE HEMATOCRIT ALERT

View all 8 devices →

Related Devices (Code: MQS)

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.

K232283PhySoftAMS®Physician Software Systems, LLCK180410Dosis SAMDosis, Inc.K130579PHYSOFT AMSPhysicians Software Systems, LLCK042566VASC-ALERTVasc-Alert, Inc.K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.

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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