The following data is part of a premarket notification filed by Pulsion Medical Systems, Inc. with the FDA for Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion In-line Injectate Sensor.
| Device ID | K991886 |
| 510k Number | K991886 |
| Device Name: | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR |
| Classification | Probe, Thermodilution |
| Applicant | PULSION MEDICAL SYSTEMS, INC. 8911 SEDGLEY DR. Wilmington, NC 28412 |
| Contact | Ulf Borg |
| Correspondent | Ulf Borg PULSION MEDICAL SYSTEMS, INC. 8911 SEDGLEY DR. Wilmington, NC 28412 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 2000-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24250094500188 | K991886 | 000 |
| 24250094500171 | K991886 | 000 |
| 24250094500089 | K991886 | 000 |