SCHULDT* PLUS 8 T.E.N.S. DEVICE
FDA 510(k) clearance K864368 · decided 1987-02-26
Clearance details
- K-number
- K864368
- Device name
- SCHULDT* PLUS 8 T.E.N.S. DEVICE
- Applicant
- Schuldt Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-05
- Decision date
- 1987-02-26
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Canada V1y 2g4, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.