510(k) K934367
K934367 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "PC-MINI". The FDA issued a decision of Substantially Equivalent on November 8, 1993. The device falls under product code JYD (Chisel, Mastoid), a Class I device regulated under 21 CFR 878.4800. GE Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1993
- Date Received
- September 7, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chisel, Mastoid
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type