The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for Transducer Protector.
| Device ID | K912394 |
| 510k Number | K912394 |
| Device Name: | TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
| Contact | Larry Larkin |
| Correspondent | Larry Larkin FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-08-30 |