FDA 510(k)

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

K-Nummer: K203332 · 2021-02-25

AntragstellerHetaida Technology Co., Ltd.

Entscheidungsdatum2021-02-25

ProduktcodeFLL

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203332. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K203332.

When did Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C receive FDA 510(k) clearance?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203332.

Who is the listed applicant for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

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

What is the FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

The FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is FLL.

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

Weitere Einträge mit Hetaida Technology Co., Ltd. als Antragsteller

K243661Electronic Blood Pressure Monitor K241202Electric nasal aspirator (HTD2601US)K223170Electronic Blood Pressure Monitor, model: HTD6602US K200159Non-contact Infrared Body Thermometer, model:HTD8823US K180387Infrared Ear Thermometer K171888Non-contact infrared body thermometer

Alle 8 Geräte anzeigen →

Verwandte Geräte (Code: FLL)

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

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.