The following data is part of a premarket notification filed by Excel Medical Systems, Inc. with the FDA for Excel Model 2110.
Device ID | K910727 |
510k Number | K910727 |
Device Name: | EXCEL MODEL 2110 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | EXCEL MEDICAL SYSTEMS, INC. 2351 DAMASCUS COURT San Jose, CA 95125 |
Contact | Glen Bovard |
Correspondent | Glen Bovard EXCEL MEDICAL SYSTEMS, INC. 2351 DAMASCUS COURT San Jose, CA 95125 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-20 |
Decision Date | 1992-01-17 |