The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Flexiport Ecocuff.
| Device ID | K122058 |
| 510k Number | K122058 |
| Device Name: | FLEXIPORT ECOCUFF |
| Classification | Blood Pressure Cuff |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-13 |
| Decision Date | 2012-11-05 |
| Summary: | summary |