AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE— 510(k) K103308

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K103308 for AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE, Substantially Equivalent on 2011-08-29. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

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.