The following data is part of a premarket notification filed by Somatics, Inc. with the FDA for Thymapad.
Device ID | K882809 |
510k Number | K882809 |
Device Name: | THYMAPAD |
Classification | Electrode, Cutaneous |
Applicant | SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
Contact | Abrams, Md |
Correspondent | Abrams, Md SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-07 |
Decision Date | 1988-09-27 |