The following data is part of a premarket notification filed by Princeton Applied Research Corp. with the FDA for Signal Averager Model 4202.
Device ID | K781290 |
510k Number | K781290 |
Device Name: | SIGNAL AVERAGER MODEL 4202 |
Classification | Conditioner, Signal, Physiological |
Applicant | PRINCETON APPLIED RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWK |
CFR Regulation Number | 882.1845 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-27 |
Decision Date | 1978-09-15 |