The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Tranducer Protector.
| Device ID | K970536 |
| 510k Number | K970536 |
| Device Name: | MEDISYSTEMS TRANDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | MEDISYSTEMS CORP. 1201 3RD AVE. SUITE 3900 Seattle, WA 98101 -3016 |
| Contact | Fred G Swindler |
| Correspondent | Fred G Swindler MEDISYSTEMS CORP. 1201 3RD AVE. SUITE 3900 Seattle, WA 98101 -3016 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-05-12 |
| Summary: | summary |