The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Single Patient Use Blood Pressure Cuff.
| Device ID | K071244 |
| 510k Number | K071244 |
| Device Name: | MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2008-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30080196358643 | K071244 | 000 |
| 10080196738922 | K071244 | 000 |
| 10080196738946 | K071244 | 000 |
| 10080196738953 | K071244 | 000 |
| 30888277190751 | K071244 | 000 |
| 20888277367415 | K071244 | 000 |
| 20888277367422 | K071244 | 000 |
| 20888277367439 | K071244 | 000 |
| 10888277637719 | K071244 | 000 |
| 10888277637733 | K071244 | 000 |
| 20888277637747 | K071244 | 000 |
| 10888277637771 | K071244 | 000 |
| 10888277637795 | K071244 | 000 |
| 10080196357550 | K071244 | 000 |
| 10080196771349 | K071244 | 000 |