The following data is part of a premarket notification filed by Ssi Medical Services, Inc. with the FDA for Clinitron At Home Air Fluided Therapy.
| Device ID | K942184 |
| 510k Number | K942184 |
| Device Name: | CLINITRON AT HOME AIR FLUIDED THERAPY |
| Classification | Bed, Air Fluidized |
| Applicant | SSI MEDICAL SERVICES, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Contact | Thomas E Mcfadden |
| Correspondent | Thomas E Mcfadden SSI MEDICAL SERVICES, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-04 |
| Decision Date | 1995-02-07 |