The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model M1310a, Series 50t Fetal Telemetry System.
| Device ID | K942887 |
| 510k Number | K942887 |
| Device Name: | MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1994-08-15 |