MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)— 510(k) K970965
Substantially EquivalentMidas Rex Pneumatic Tools, Inc.
FDA 510(k) clearance K970965 for MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III), Substantially Equivalent on 1997-04-09. Applicant: Midas Rex Pneumatic Tools, Inc.. Device class: 2.
Clearance details
- Applicant
- Midas Rex Pneumatic Tools, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code ERL
view allMore clearances from Midas Rex Pneumatic Tools, Inc.
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.