Midas Rex Motors, (Midas I, Midas II & Convertible Models)
FDA 510(k) K953434 · Midas Rex Pneumatic Tools, Inc.
510(k) numberK953434
Submission
- Device name
- Midas Rex Motors, (Midas I, Midas II & Convertible Models)
- Applicant
- Midas Rex Pneumatic Tools, Inc.
Fort Worth, TX, US - Received
- July 21, 1995
- Decision date
- May 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
| K972289 | Midas Rex MotorHBB · Traditional | 09/12/1997SE |
| K970965 | Midas Rex III Motor and Attachments (Midas III)ERL · Traditional | 04/09/1997SE |
| K962483 | Midas Rex III MotorHBB · Traditional | 11/19/1996SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | 09/15/1995SE |
| K953432 | Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional | 09/14/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | 05/26/1995SE |
| K900388 | Modified Sterilization of Drills, Burrs, TrephinesHBE · Traditional | 05/07/1990SE |
| K854462 | Midas Rex Surgical Rubber Dam · Traditional | 11/22/1985SE |
Questions and answers
When was Midas Rex Motors, (Midas I, Midas II & Convertible Models) cleared by the FDA?
Midas Rex Motors, (Midas I, Midas II & Convertible Models) (K953434) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 300 days after the submission was received.
What is the product code of K953434?
The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.