DYNASOUND 801— 510(k) K811159
Substantially EquivalentDynawave, Corp.
FDA 510(k) clearance K811159 for DYNASOUND 801, Substantially Equivalent on 1981-05-27. Applicant: Dynawave, Corp.. Device class: 2.
Clearance details
- Applicant
- Dynawave, Corp.
- Product code
- Code IMI
- Device class
- Class 2
- Regulation
- 21 CFR 890.5300
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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