CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR— 510(k) K904360
Substantially EquivalentMaximum Performance Technologies, Mpts, Inc.
FDA 510(k) clearance K904360 for CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR, Substantially Equivalent on 1991-10-15. Applicant: Maximum Performance Technologies, Mpts, Inc.. Device class: 2.
Clearance details
- Applicant
- Maximum Performance Technologies, Mpts, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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