The following data is part of a premarket notification filed by Quantitative Medicine, Inc. with the FDA for Quantitative Sentinel System.
| Device ID | K960109 |
| 510k Number | K960109 |
| Device Name: | QUANTITATIVE SENTINEL SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | QUANTITATIVE MEDICINE, INC. 200 HARRY S. TRUMAN PKWY. SUITE 220 Annapolis, MD 21401 |
| Contact | Maria Vitug Fouts |
| Correspondent | Maria Vitug Fouts QUANTITATIVE MEDICINE, INC. 200 HARRY S. TRUMAN PKWY. SUITE 220 Annapolis, MD 21401 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-08-01 |
| Summary: | summary |