TENS MAX— 510(k) K823388
Substantially EquivalentFujisawa Electronics Co.
FDA 510(k) clearance K823388 for TENS MAX, Substantially Equivalent on 1983-01-08. Applicant: Fujisawa Electronics Co.. Device class: 2.
Clearance details
- Applicant
- Fujisawa Electronics Co.
- Product code
- Code GFK
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.