510(k) K782164
K782164 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "STIMULATOR, MODEL 1-600 ELECTRIC NERVR". The FDA issued a decision of Substantially Equivalent on March 8, 1979. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1979
- Date Received
- December 22, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type