The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Vsm Models A & B.
| Device ID | K851916 |
| 510k Number | K851916 |
| Device Name: | VSM MODELS A & B |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Gail E Nova |
| Correspondent | Gail E Nova PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-02 |
| Decision Date | 1985-08-19 |