FDA 510(k)

MEMO Patch M (MPT-E08R-UNC01)

K-Nummer: K243438 · 2025-12-05

Entscheidungsdatum2025-12-05

ProduktcodeDXH

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

MEMO Patch M (MPT-E08R-UNC01) is the device name listed in this FDA 510(k) record. The listed applicant is Huinno Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K243438. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the MEMO Patch M (MPT-E08R-UNC01)?

MEMO Patch M (MPT-E08R-UNC01) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Huinno Co., Ltd.. The 510(k) number is K243438.

When did MEMO Patch M (MPT-E08R-UNC01) receive FDA 510(k) clearance?

MEMO Patch M (MPT-E08R-UNC01) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K243438.

Who is the listed applicant for MEMO Patch M (MPT-E08R-UNC01)?

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

What is the FDA product code for MEMO Patch M (MPT-E08R-UNC01)?

The FDA product code for MEMO Patch M (MPT-E08R-UNC01) is DXH. This falls under the Hematology category.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Verwandte Geräte (Code: DXH)

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.