The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett Packard Model M1353a Fetal Monitor.
| Device ID | K921956 |
| 510k Number | K921956 |
| Device Name: | HEWLETT PACKARD MODEL M1353A FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Contact | Erich Courtin |
| Correspondent | Erich Courtin HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1993-09-24 |