FDA 510(k)

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

Número K: K193438 · 2020-06-02

Data da decisão2020-06-02

Código do produtoHBL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) 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 2020-06-02 under 510(k) number K193438. 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 Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Pro Med Instruments GmbH. The 510(k) number is K193438.

When did DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) receive FDA 510(k) clearance?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) received FDA 510(k) clearance on 2020-06-02, under 510(k) number K193438.

Who is the listed applicant for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

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 Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

The FDA product code for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is HBL.

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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)K203505DORO QR3 Headrest System (Aluminum)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 K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH K191701Quadro de Fixação de Cabeça ArcusMri Interventions, Inc.

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