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 |