510(k) K830597
K830597 is an FDA 510(k) premarket notification submitted by Precision Cap Systems for the device "BABY CAP, ELECTRODE SET & BOARD ADAPTOR". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Precision Cap Systems has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- February 24, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type