MICROSEPT 60/20— 510(k) K890844

Substantially Equivalent

Arbor Technologies, Inc.

FDA 510(k) clearance K890844 for MICROSEPT 60/20, Substantially Equivalent on 1989-06-07. Applicant: Arbor Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Arbor Technologies, Inc.
Product code
Code CAK
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAK

product code CAK
Malfunction
476
Total
476

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.