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FDA 510(k)

DORO QR3 Headrest System (Aluminum)

K-Number: K203505 · 2021-03-29

ApplicantPro Med Instruments GmbH
Decision Date2021-03-29
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DORO QR3 Headrest System (Aluminum) is a medical device manufactured by Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2021-03-29 under approval number K203505. 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 QR3 Headrest System (Aluminum)?

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

When was DORO QR3 Headrest System (Aluminum) approved by the FDA?

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

What company makes DORO QR3 Headrest System (Aluminum)?

DORO QR3 Headrest System (Aluminum) is manufactured by Pro Med Instruments GmbH.

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

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

Other Devices by Pro Med Instruments GmbH

K191979DORO QR3 XTom Headholder System K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) K191740DORO LUCENT® iXI and iMRI Headrest System 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)

Related Devices (Code: HBL)

K163322TZ SKULL PIN AdultTz Medical, Inc. K191701Arcus Head Fixation FrameMri Interventions, Inc. K191979DORO QR3 XTom Headholder SystemPro 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 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

Official Source

View on FDA Database →

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

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