Theradome LH80 PRO— 510(k) K171775
Substantially EquivalentTheradome, Inc.
FDA 510(k) clearance K171775 for Theradome LH80 PRO, Substantially Equivalent on 2018-01-09. Applicant: Theradome, Inc.. Device class: 2.
Clearance details
- Applicant
- Theradome, Inc.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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