The following data is part of a premarket notification filed by Ferno-washington, Inc. with the FDA for Ferno Healthcare Recline-a-bath 2.
| Device ID | K980033 |
| 510k Number | K980033 |
| Device Name: | FERNO HEALTHCARE RECLINE-A-BATH 2 |
| Classification | Bath, Hydro-massage |
| Applicant | FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington, OH 45177 |
| Contact | Eric N Besanko |
| Correspondent | Eric N Besanko FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington, OH 45177 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-05 |
| Decision Date | 1998-04-21 |