HPM-6000UF— 510(k) K181497
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K181497 for HPM-6000UF, Substantially Equivalent on 2018-11-14. Applicant: BTL Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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More clearances from BTL Industries, Inc.
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