DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS— 510(k) K063494
Substantially EquivalentPro-Med Instruments GmbH
FDA 510(k) clearance K063494 for DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS, Substantially Equivalent on 2007-05-21. Applicant: Pro-Med Instruments GmbH. Device class: 2.
Clearance details
- Applicant
- Pro-Med Instruments GmbH
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lehigh Acres, FL, US
Recent devices under product code HBL
view all- K250423 — mb-FIX Cranial Stabilization Systems
- K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) +4 more
- K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
- K203505 — DORO QR3 Headrest System (Aluminum)
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
More clearances from Pro-Med Instruments GmbH
view all- K191740 — DORO LUCENT® iXI and iMRI Headrest System
- K191979 — DORO QR3 XTom Headholder System
- K070997 — DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
- K032331 — DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
- K001808 — DORO HEADREST SYSTEM
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.