The following data is part of a premarket notification filed by Mantra Intl. (hk) Ltd. with the FDA for Mantra Electrode.
| Device ID | K041902 |
| 510k Number | K041902 |
| Device Name: | MANTRA ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | MANTRA INTL. (HK) LTD. 10235 GLADE AVE. Chatsworth, CA 91311 |
| Contact | Robert B Spertell |
| Correspondent | Robert B Spertell MANTRA INTL. (HK) LTD. 10235 GLADE AVE. Chatsworth, CA 91311 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-14 |
| Decision Date | 2004-09-22 |
| Summary: | summary |