The following data is part of a premarket notification filed by Magna Advanced Technologies, Inc. with the FDA for Mtek-1000.
| Device ID | K982405 |
| 510k Number | K982405 |
| Device Name: | MTEK-1000 |
| Classification | Oximeter |
| Applicant | MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami, FL 33126 |
| Contact | Annie Velez |
| Correspondent | Annie Velez MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami, FL 33126 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-09-17 |