MIDAS REX MOTOR— 510(k) K972289

Name: FDA 510(k) clearance K972289
Creator: U.S. Food and Drug Administration
Published: 1997-09-12

Substantially Equivalent

Midas Rex Pneumatic Tools, Inc.

FDA 510(k) clearance K972289 for MIDAS REX MOTOR, Substantially Equivalent on 1997-09-12. 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: 1997-06-19
Decision date: 1997-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Midas Rex Pneumatic Tools, Inc.

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K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)1997-04-09
K962483 — MIDAS REX III MOTOR1996-11-19
K953434 — MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)1996-05-16
K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS1995-10-18
K953433 — MIDAS REX TELESCOPING SYSTEM1995-09-15

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.