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 |