THE DOME GX4MP COLOR NONITOR— 510(k) K120709
Substantially EquivalentNds Surgical Imaging
FDA 510(k) clearance K120709 for THE DOME GX4MP COLOR NONITOR, Substantially Equivalent on 2012-04-06. Applicant: Nds Surgical Imaging. Device class: 2.
Clearance details
- Applicant
- Nds Surgical Imaging
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code LLZ
view allMore clearances from Nds Surgical Imaging
view all- K133609 — THE DOME S6C
- K132770 — DOME S10
- K131115 — ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
- K100195 — NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
- K080320 — PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.