The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Series 50xm.
| Device ID | K954351 |
| 510k Number | K954351 |
| Device Name: | SERIES 50XM |
| Classification | System, Monitoring, Perinatal |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1996-03-08 |
| Summary: | summary |