The following data is part of a premarket notification filed by Mars Medical Products with the FDA for Ms-900s, Ms-900spm & Ms-900sfm.
| Device ID | K980845 |
| 510k Number | K980845 |
| Device Name: | MS-900S, MS-900SPM & MS-900SFM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MARS MEDICAL PRODUCTS P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith MARS MEDICAL PRODUCTS P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-04 |
| Decision Date | 1998-12-14 |