The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Vsm(r) R2 Paper Chart Recorder.
| Device ID | K880554 |
| 510k Number | K880554 |
| Device Name: | VSM(R) R2 PAPER CHART RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Sherri L Pocock |
| Correspondent | Sherri L Pocock PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-05-06 |