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FDA 510(k)

CARDNAV

K-Number: K120282 · 2012-12-10

ApplicantPaieon, Inc.
Decision Date2012-12-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDNAV is the device name listed in this FDA 510(k) record. The listed applicant is Paieon, Inc.. It received FDA 510(k) clearance on 2012-12-10 under 510(k) number K120282. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDNAV?

CARDNAV is a medical device that received FDA 510(k) clearance on 2012-12-10. The listed applicant is Paieon, Inc.. The 510(k) number is K120282.

When did CARDNAV receive FDA 510(k) clearance?

CARDNAV received FDA 510(k) clearance on 2012-12-10, under 510(k) number K120282.

Who is the listed applicant for CARDNAV?

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

What is the FDA product code for CARDNAV?

The FDA product code for CARDNAV is OWB.

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Other records listing Paieon, Inc. 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.

K113594C-THV SYSTEMK110256THE IC-PRO SYSTEMK083745THE IC-PRO SYSTEM, MODEL VERSION 3.2K082907IC-PRO SYSTEM, VERSION 3.1.0.4K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVAK072591CARDIOP-B SYSTEM, VERSION 2.1

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Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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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