The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model M1403a Telemetry Monitoring Systems (tms).
| Device ID | K913533 |
| 510k Number | K913533 |
| Device Name: | MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| 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 | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-11-07 |