The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Flexiport Disposable Blood Pressure Cuff (one-piece); Reusable Blood Pressure Cuff (one-piece).
| Device ID | K070060 |
| 510k Number | K070060 |
| Device Name: | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) |
| Classification | Blood Pressure Cuff |
| Applicant | WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Sawyer |
| Correspondent | John Sawyer WELCH ALLYN, INC. 4341 STATE STREET ROAD PO 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 | 2007-01-05 |
| Decision Date | 2007-12-18 |
| Summary: | summary |