The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Vital Signs Monitor 2.
| Device ID | K830587 |
| 510k Number | K830587 |
| Device Name: | VITAL SIGNS MONITOR 2 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PHYSIO-CONTROL CORP. WA |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-06-08 |