The following data is part of a premarket notification filed by Intl. Medication Systems, Ltd. with the FDA for The California Splint.
| Device ID | K854752 |
| 510k Number | K854752 |
| Device Name: | THE CALIFORNIA SPLINT |
| Classification | Blood Pressure Cuff |
| Applicant | INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
| Contact | Diane Gillett |
| Correspondent | Diane Gillett INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-26 |
| Decision Date | 1985-12-17 |