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FDA 510(k)

TRENDCARE CALIBRATOR MODEL SCU 7007

K-Number: K983198 · 1999-11-23

ApplicantDiametrics Medical, Ltd.
Decision Date1999-11-23
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRENDCARE CALIBRATOR MODEL SCU 7007 is the device name listed in this FDA 510(k) record. The listed applicant is Diametrics Medical, Ltd.. It received FDA 510(k) clearance on 1999-11-23 under 510(k) number K983198. The device is classified under product code CCC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRENDCARE CALIBRATOR MODEL SCU 7007?

TRENDCARE CALIBRATOR MODEL SCU 7007 is a medical device that received FDA 510(k) clearance on 1999-11-23. The listed applicant is Diametrics Medical, Ltd.. The 510(k) number is K983198.

When did TRENDCARE CALIBRATOR MODEL SCU 7007 receive FDA 510(k) clearance?

TRENDCARE CALIBRATOR MODEL SCU 7007 received FDA 510(k) clearance on 1999-11-23, under 510(k) number K983198.

Who is the listed applicant for TRENDCARE CALIBRATOR MODEL SCU 7007?

The FDA 510(k) record lists Diametrics Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRENDCARE CALIBRATOR MODEL SCU 7007?

The FDA product code for TRENDCARE CALIBRATOR MODEL SCU 7007 is CCC.

Related Clinical Trials

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Other records listing Diametrics Medical, Ltd. 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.

K980380NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MSK972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMK970906PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR

Related Devices (Code: CCC)

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.

K071165ISCALERT SENSOR SYSTEMAlertis Medical ASK972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, Inc.K951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMOptical Sensors, 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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