MIDAS REX III MOTOR— 510(k) K962483

Substantially Equivalent

Midas Rex Pneumatic Tools, Inc.

FDA 510(k) clearance K962483 for MIDAS REX III MOTOR, Substantially Equivalent on 1996-11-19. Applicant: Midas Rex Pneumatic Tools, Inc.. Device class: 2.

Clearance details

Applicant
Midas Rex Pneumatic Tools, Inc.
Product code
Code HBB
Device class
Class 2
Regulation
21 CFR 882.4370
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Worth, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HBB

product code HBB
Malfunction
2,656
Total
2,656

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.