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FDA 510(k)

RADIANALYZER, MODEL 12710

K-Number: K002067 · 2001-01-11

ApplicantRadi Medical Systems AB
Decision Date2001-01-11
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIANALYZER, MODEL 12710 is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K002067. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIANALYZER, MODEL 12710?

RADIANALYZER, MODEL 12710 is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Radi Medical Systems AB. The 510(k) number is K002067.

When did RADIANALYZER, MODEL 12710 receive FDA 510(k) clearance?

RADIANALYZER, MODEL 12710 received FDA 510(k) clearance on 2001-01-11, under 510(k) number K002067.

Who is the listed applicant for RADIANALYZER, MODEL 12710?

The FDA 510(k) record lists Radi Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIANALYZER, MODEL 12710?

The FDA product code for RADIANALYZER, MODEL 12710 is DSK.

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Other records listing Radi Medical Systems AB 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.

K123984QUANTIEN MEASUREMENT SYSTEMK092105RADIANALYZER XPRESSK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711

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Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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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