DeviceClearance

AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5— 510(k) K100750

Substantially Equivalent

Aalto Scientific, Ltd.

FDA 510(k) clearance K100750 for AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5, Substantially Equivalent on 2010-05-21. Applicant: Aalto Scientific, Ltd..

Clearance details

Applicant
Aalto Scientific, Ltd.
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.