The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Guardian 150 Electrode.
| Device ID | K083756 |
| 510k Number | K083756 |
| Device Name: | GUARDIAN 150 ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | SELECTIVE MED COMPONENTS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour SELECTIVE MED COMPONENTS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-06-26 |
| Summary: | summary |