The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Multiday, Models 8300 And 8310.
Device ID | K882888 |
510k Number | K882888 |
Device Name: | MULTIDAY, MODELS 8300 AND 8310 |
Classification | Electrode, Cutaneous |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | Bruce Macfarlane,phd |
Correspondent | Bruce Macfarlane,phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-09-30 |