The following data is part of a premarket notification filed by Pulseflow Technologies with the FDA for Pulseflowdf.
| Device ID | K150806 |
| 510k Number | K150806 |
| Device Name: | PulseFlowDF |
| Classification | Sleeve, Limb, Compressible |
| Applicant | PulseFlow Technologies Midshires House Midshires Business Park Aylesbury, GB Hp19 8hl |
| Contact | Les Lindsay |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants 2995 Steven Martin Dr. Fairfax, VA 22031 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-26 |
| Decision Date | 2015-12-16 |
| Summary: | summary |