The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt Vaxiom Stereotactic Sys #fx001.
| Device ID | K831329 |
| 510k Number | K831329 |
| Device Name: | PMT VAXIOM STEREOTACTIC SYS #FX001 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PROGRESS MANKIND TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-25 |
| Decision Date | 1983-06-15 |