The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Singe Patient Use Blood Pressure Cuff.
| Device ID | K161035 |
| 510k Number | K161035 |
| Device Name: | Medline Singe 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 | 2016-04-13 |
| Decision Date | 2016-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884389976071 | K161035 | 000 |