| Device Classification Name |
Recorder, Paper Chart
|
| 510(k) Number |
K880554 |
| Device Name |
VSM(R) R2 PAPER CHART RECORDER |
| Applicant |
| Physio-Control Corp. |
| 11811 Willows Rd., NE |
| P.O. Box 97006 |
|
Redmond,
WA
98073
|
|
| Applicant Contact |
SHERRI L POCOCK |
| Correspondent |
| Physio-Control Corp. |
| 11811 Willows Rd., NE |
| P.O. Box 97006 |
|
Redmond,
WA
98073
|
|
| Correspondent Contact |
SHERRI L POCOCK |
| Regulation Number | 870.2810 |
| Classification Product Code |
|
| Date Received | 02/09/1988 |
| Decision Date | 05/06/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|