The following data is part of a premarket notification filed by Bio-med Usa Inc. with the FDA for Wandy Dispersvie Electrode.
| Device ID | K121268 |
| 510k Number | K121268 |
| Device Name: | WANDY DISPERSVIE ELECTRODE |
| Classification | Electrosurgical Patient Return Electrode |
| Applicant | BIO-MED USA INC. 111 ELLISON STREET Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED USA INC. 111 ELLISON STREET Paterson, NJ 07505 |
| Product Code | ODR |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2012-12-20 |
| Summary: | summary |