The following data is part of a premarket notification filed by Pulsion Medical Systems Ag with the FDA for Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing Pv 4046.
| Device ID | K020587 |
| 510k Number | K020587 |
| Device Name: | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 |
| Classification | Probe, Thermodilution |
| Applicant | PULSION MEDICAL SYSTEMS AG 100 MAIN ST. STE. 120 Concord, MA 01742 |
| Contact | James M Delaney |
| Correspondent | James M Delaney PULSION MEDICAL SYSTEMS AG 100 MAIN ST. STE. 120 Concord, MA 01742 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2002-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250094500153 | K020587 | 000 |