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FDA 510(k)

MODIFICATION TO: RADIANALYZER, MODEL 12711

K-Number: K042628 · 2005-01-19

ApplicantRadi Medical Systems AB
Decision Date2005-01-19
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: RADIANALYZER, MODEL 12711 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 2005-01-19 under 510(k) number K042628. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: RADIANALYZER, MODEL 12711?

MODIFICATION TO: RADIANALYZER, MODEL 12711 is a medical device that received FDA 510(k) clearance on 2005-01-19. The listed applicant is Radi Medical Systems AB. The 510(k) number is K042628.

When did MODIFICATION TO: RADIANALYZER, MODEL 12711 receive FDA 510(k) clearance?

MODIFICATION TO: RADIANALYZER, MODEL 12711 received FDA 510(k) clearance on 2005-01-19, under 510(k) number K042628.

Who is the listed applicant for MODIFICATION TO: RADIANALYZER, MODEL 12711?

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 MODIFICATION TO: RADIANALYZER, MODEL 12711?

The FDA product code for MODIFICATION TO: RADIANALYZER, MODEL 12711 is DQK.

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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 12306K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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