FDA 510(k)

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Número K: K240319 · 2024-04-24

Data da decisão2024-04-24

Código do produtoHBL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) 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 2024-04-24 under 510(k) number K240319. 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 LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Pro Med Instruments GmbH. The 510(k) number is K240319.

When did DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) receive FDA 510(k) clearance?

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K240319.

Who is the listed applicant for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

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 LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

The FDA product code for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) 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)K203505DORO QR3 Headrest System (Aluminum)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 K203505DORO QR3 Headrest System (Aluminum)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.

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