The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Tru-pulse Pads.
Device ID | K800117 |
510k Number | K800117 |
Device Name: | TRU-PULSE PADS |
Classification | Electrode, Cutaneous |
Applicant | IPCO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-18 |
Decision Date | 1980-02-11 |