PULSIOFLEX
Computer, Diagnostic, Pre-programmed, Single-function
PULSION MEDICAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Pulsion Medical Systems, Inc. with the FDA for Pulsioflex.
Pre-market Notification Details
| Device ID | K112448 |
| 510k Number | K112448 |
| Device Name: | PULSIOFLEX |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION MEDICAL SYSTEMS, INC. 1511 ESSEX RD Westbrook, CT 06498 |
| Contact | Jamie Sulley |
| Correspondent | Jamie Sulley PULSION MEDICAL SYSTEMS, INC. 1511 ESSEX RD Westbrook, CT 06498 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2011-09-22 |
Trademark Results [PULSIOFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULSIOFLEX 79087141 4036950 Live/Registered |
Pulsion Medical Systems SE 2010-08-13 |
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