The following data is part of a premarket notification filed by Lorin Medical, Inc. with the FDA for Cuff-m.
| Device ID | K921997 |
| 510k Number | K921997 |
| Device Name: | CUFF-M |
| Classification | Blood Pressure Cuff |
| Applicant | LORIN MEDICAL, INC. 1700 NORTH DIXIE HWY. #130 Boca Raton, FL 33432 |
| Contact | Norbet J Schmitt |
| Correspondent | Norbet J Schmitt LORIN MEDICAL, INC. 1700 NORTH DIXIE HWY. #130 Boca Raton, FL 33432 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1992-07-23 |