FDA 510(k)

DORO QR3 Headrest System (Aluminum)

Número K: K203505 · 2021-03-29

Data da decisão2021-03-29

Código do produtoHBL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DORO QR3 Headrest System (Aluminum) is the device name listed in this FDA 510(k) record. The listed applicant is Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2021-03-29 under 510(k) number K203505. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DORO QR3 Headrest System (Aluminum)?

DORO QR3 Headrest System (Aluminum) is a medical device that received FDA 510(k) clearance on 2021-03-29. The listed applicant is Pro Med Instruments GmbH. The 510(k) number is K203505.

When did DORO QR3 Headrest System (Aluminum) receive FDA 510(k) clearance?

DORO QR3 Headrest System (Aluminum) received FDA 510(k) clearance on 2021-03-29, under 510(k) number K203505.

Who is the listed applicant for DORO QR3 Headrest System (Aluminum)?

The FDA 510(k) record lists Pro Med Instruments GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORO QR3 Headrest System (Aluminum)?

The FDA product code for DORO QR3 Headrest System (Aluminum) is HBL.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Pro Med Instruments GmbH como candidato(a)

K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)K191740DORO LUCENT® iXI and iMRI Headrest System K191979DORO QR3 XTom Headholder System

Dispositivos Relacionados (Código: HBL)

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH K191701Quadro de Fixação de Cabeça ArcusMri Interventions, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.