The following data is part of a premarket notification filed by Ssi Medical Services, Inc. with the FDA for Acucair Cushion Continuous Airflow System.
| Device ID | K882161 |
| 510k Number | K882161 |
| Device Name: | ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | SSI MEDICAL SERVICES, INC. BURDITT RADZIUS CHARTERED 333 W.WACKER DR.SUITE 2600 Chicago, IL 60606 |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius SSI MEDICAL SERVICES, INC. BURDITT RADZIUS CHARTERED 333 W.WACKER DR.SUITE 2600 Chicago, IL 60606 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-23 |
| Decision Date | 1988-07-12 |