The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model M2350a And M2360a Wavevue Central Monitor.
| Device ID | K921014 |
| 510k Number | K921014 |
| Device Name: | MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Contact | David Osborn |
| Correspondent | David Osborn HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-10-01 |