The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Model Icpm & Accessories.
Device ID | K823681 |
510k Number | K823681 |
Device Name: | MODEL ICPM & ACCESSORIES |
Classification | System, Pressure Measurement, Intermittent |
Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFC |
CFR Regulation Number | 890.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-07 |
Decision Date | 1983-02-23 |