TE-800 PELVIC FLOOR EXERCISER— 510(k) K945937
Substantially EquivalentMyo/Kinetic Systems, Inc.
FDA 510(k) clearance K945937 for TE-800 PELVIC FLOOR EXERCISER, Substantially Equivalent on 1995-07-14. Applicant: Myo/Kinetic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Myo/Kinetic Systems, Inc.
- Product code
- Code HIR
- Device class
- Class 2
- Regulation
- 21 CFR 884.1425
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menomonee Falls, WI, US
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