K934367 is an FDA 510(k) clearance for the PC-MINI. This device is classified as a Chisel, Mastoid (Class I - General Controls, product code JYD).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 8, 1993, 62 days after receiving the submission on September 7, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K934367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1993 |
| Decision Date | November 08, 1993 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JYD - Chisel, Mastoid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |