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FDA 510(k)

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER

K-Number: K080813 · 2008-07-01

ApplicantRadi Medical Systems AB
Decision Date2008-07-01
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER 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 2008-07-01 under 510(k) number K080813. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER?

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Radi Medical Systems AB. The 510(k) number is K080813.

When did PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER receive FDA 510(k) clearance?

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER received FDA 510(k) clearance on 2008-07-01, under 510(k) number K080813.

Who is the listed applicant for PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER?

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 PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER?

The FDA product code for PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER is DXO.

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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 XPRESSK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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