The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Solaris Reusable And Disposable Blood Pressure Cuffs.
| Device ID | K101972 |
| 510k Number | K101972 |
| Device Name: | SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS |
| Classification | Blood Pressure Cuff |
| Applicant | SOLARIS MEDICAL TECHNOLOGY, INC. 400 OYSTER POINT BLVD. SUITE 534 South San Francisco, CA 94080 |
| Contact | Rachel Cheng |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2010-07-22 |