The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for Model Msc Sa02-5000 Pulse Oximeter.
| Device ID | K902192 |
| 510k Number | K902192 |
| Device Name: | MODEL MSC SA02-5000 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Contact | Mardin Varela |
| Correspondent | Mardin Varela MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-23 |