DeviceClearance

MODIFICATION TO AUTOFUSER— 510(k) K090300

Substantially Equivalent

Ace Medical Us, LLC

FDA 510(k) clearance K090300 for MODIFICATION TO AUTOFUSER, Substantially Equivalent on 2009-04-30. Applicant: Ace Medical Us, LLC. Device class: 2.

Clearance details

Applicant
Ace Medical Us, LLC
Product code
Code MEB
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Powell, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MEB

product code MEB
Death
6
Injury
160
Malfunction
10,053
Other
5
Total
10,224

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 →

Recalls naming K090300

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090300.

Data sourced from openFDA. This site is unofficial and independent of the FDA.