The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite A Blood Acetaminophen Monitoring System.
| Device ID | K897118 |
| 510k Number | K897118 |
| Device Name: | SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM |
| Classification | Colorimetry, Acetaminophen |
| Applicant | MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Contact | Lias, Ph.d. |
| Correspondent | Lias, Ph.d. MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-05-10 |