FDA 510(k)

DORO HEADREST SYSTEM

K-Number: K001808 · 2000-08-04

Decision Date2000-08-04

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DORO HEADREST SYSTEM 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 2000-08-04 under 510(k) number K001808. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORO HEADREST SYSTEM?

DORO HEADREST SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Pro-Med Instruments GmbH. The 510(k) number is K001808.

When did DORO HEADREST SYSTEM receive FDA 510(k) clearance?

DORO HEADREST SYSTEM received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001808.

Who is the listed applicant for DORO HEADREST SYSTEM?

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 HEADREST SYSTEM?

The FDA product code for DORO HEADREST SYSTEM is HBL.

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Other records listing Pro-Med Instruments GmbH as applicant

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)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

View all 10 devices →

Related Devices (Code: 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 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.