5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307— 510(k) K863096

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K863096 for 5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307, Substantially Equivalent on 1986-11-10. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Medical Solutions USA, Inc.
Product code
Code IYO
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Iselin, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

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.