The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Odis - Obstetrical Display Info System, Hp M1370a.
| Device ID | K892354 |
| 510k Number | K892354 |
| Device Name: | ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A |
| Classification | System, Monitoring, Perinatal |
| Applicant | HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Contact | Ernst Schalk |
| Correspondent | Ernst Schalk 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 | 1989-03-10 |
| Decision Date | 1989-08-08 |