TENSMED II— 510(k) K851063
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K851063 for TENSMED II, Substantially Equivalent on 1985-06-04. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freeport, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.