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FDA 510(k)

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR

K-Number: K970906 · 1997-09-23

ApplicantDiametrics Medical, Ltd.
Decision Date1997-09-23
Product CodeCBZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR 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 1997-09-23 under 510(k) number K970906. The device is classified under product code CBZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR?

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR is a medical device that received FDA 510(k) clearance on 1997-09-23. The listed applicant is Diametrics Medical, Ltd.. The 510(k) number is K970906.

When did PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR receive FDA 510(k) clearance?

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR received FDA 510(k) clearance on 1997-09-23, under 510(k) number K970906.

Who is the listed applicant for PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR?

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 PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR?

The FDA product code for PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR is CBZ.

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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.

K983198TRENDCARE CALIBRATOR MODEL SCU 7007K980380NEUROTREND 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 SYSTEM

Related Devices (Code: CBZ)

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.

K020967TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEMTerumo Cardiovascular Systems Corp.K931112MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODIPuritan Bennett Corp.K920061HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEMAbbott LaboratoriesK912030CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED3M CompanyK912428PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENTPuritan Bennett Corp.K884228CDI(R) 2000 BLOOD GAS MONITORCardiovascular Devices, 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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