FDA 510(k)

Thermidas IR System (ThIR-A615)

K-Nummer: K200999 · 2021-01-06

Entscheidungsdatum2021-01-06

ProduktcodeLHQ

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

Thermidas IR System (ThIR-A615) is the device name listed in this FDA 510(k) record. The listed applicant is Thermidas Americas, Inc.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200999. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Thermidas IR System (ThIR-A615)?

Thermidas IR System (ThIR-A615) is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Thermidas Americas, Inc.. The 510(k) number is K200999.

When did Thermidas IR System (ThIR-A615) receive FDA 510(k) clearance?

Thermidas IR System (ThIR-A615) received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200999.

Who is the listed applicant for Thermidas IR System (ThIR-A615)?

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

What is the FDA product code for Thermidas IR System (ThIR-A615)?

The FDA product code for Thermidas IR System (ThIR-A615) is LHQ.

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: LHQ)

K253911Derma-2Neko Health AB K232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private Limited K212412IRIS-XPMedicore Co., Ltd.K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health

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.