The following data is part of a premarket notification filed by Clear Medical, Inc. with the FDA for Clearmedical/critikon Blood Pressure Cuff; Clearmedical/welch Allyn Blood Pressure Cuff.
| Device ID | K031416 |
| 510k Number | K031416 |
| Device Name: | CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Contact | Lane Abenroth |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-05 |
| Decision Date | 2003-07-15 |
| Summary: | summary |