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FDA 510(k)

PERIFLUX 6000

K-Number: K131253 · 2013-10-22

ApplicantPerimed AB
Decision Date2013-10-22
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERIFLUX 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Perimed AB. It received FDA 510(k) clearance on 2013-10-22 under 510(k) number K131253. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIFLUX 6000?

PERIFLUX 6000 is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Perimed AB. The 510(k) number is K131253.

When did PERIFLUX 6000 receive FDA 510(k) clearance?

PERIFLUX 6000 received FDA 510(k) clearance on 2013-10-22, under 510(k) number K131253.

Who is the listed applicant for PERIFLUX 6000?

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

What is the FDA product code for PERIFLUX 6000?

The FDA product code for PERIFLUX 6000 is LKD.

Related Clinical Trials

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Other records listing Perimed 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.

K152930PeriFlux6000K120884PERICAM PSIK011899PF 5050 PRESSURE UNIT, MODEL PF 5050

Related Devices (Code: LKD)

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.

K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AGK110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac ANK101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AGK093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical ApsK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AGK043003TCM40 MONITORING SYSTEMRadiometer Medical Aps

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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