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FDA 510(k)

HD+12, HD+15

K-Number: K220526 · 2023-05-15

ApplicantCardioline S.P.A
Decision Date2023-05-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HD+12, HD+15 is the device name listed in this FDA 510(k) record. The listed applicant is Cardioline S.P.A. It received FDA 510(k) clearance on 2023-05-15 under 510(k) number K220526. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD+12, HD+15?

HD+12, HD+15 is a medical device that received FDA 510(k) clearance on 2023-05-15. The listed applicant is Cardioline S.P.A. The 510(k) number is K220526.

When did HD+12, HD+15 receive FDA 510(k) clearance?

HD+12, HD+15 received FDA 510(k) clearance on 2023-05-15, under 510(k) number K220526.

Who is the listed applicant for HD+12, HD+15?

The FDA 510(k) record lists Cardioline S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD+12, HD+15?

The FDA product code for HD+12, HD+15 is DRG.

Other records listing Cardioline S.P.A 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.

K160746CARDIOLINE touchECGK160840ECG100+, ECG200+

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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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