MIDAS REX MOTOR
FDA 510(k) clearance K972289 · decided 1997-09-12
Clearance details
- K-number
- K972289
- Device name
- MIDAS REX MOTOR
- Applicant
- Midas Rex Pneumatic Tools, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-19
- Decision date
- 1997-09-12
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HBB
- Device class
- 2
- Regulation number
- 882.4370
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.