H-WAVE SPORT— 510(k) K081998
Substantially EquivalentElectronic Waveform Laboratory, Inc.
FDA 510(k) clearance K081998 for H-WAVE SPORT, Substantially Equivalent on 2009-07-09. Applicant: Electronic Waveform Laboratory, Inc.. Device class: 2.
Clearance details
- Applicant
- Electronic Waveform Laboratory, Inc.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntington Beach, CA, US
Recent devices under product code NGX
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