entré Model PD08-U— 510(k) K143185
Substantially EquivalentTactile Systems Technology, Inc.
FDA 510(k) clearance K143185 for entré Model PD08-U, Substantially Equivalent on 2015-05-07. Applicant: Tactile Systems Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Tactile Systems Technology, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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