TENS MAX
FDA 510(k) clearance K823388 · decided 1983-01-08
Clearance details
- K-number
- K823388
- Device name
- TENS MAX
- Applicant
- Fujisawa Electronics Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-15
- Decision date
- 1983-01-08
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GFK
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.