The following data is part of a premarket notification filed by Phoenix Corp. with the FDA for Phoenix 60/60 Processor Module.
Device ID | K831134 |
510k Number | K831134 |
Device Name: | PHOENIX 60/60 PROCESSOR MODULE |
Classification | Recorder, Paper Chart |
Applicant | PHOENIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-07 |
Decision Date | 1983-11-07 |