The following data is part of a premarket notification filed by Arjo, Inc. with the FDA for Recumbent Bathing Systems, Rhapsody And Primo.
| Device ID | K001079 |
| 510k Number | K001079 |
| Device Name: | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO |
| Classification | Bath, Hydro-massage |
| Applicant | ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle, IL 60172 -1684 |
| Contact | David Insco |
| Correspondent | David Insco ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle, IL 60172 -1684 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-05-01 |