The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Transducer Protector.
| Device ID | K983076 |
| 510k Number | K983076 |
| Device Name: | MEDISYSTEMS TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Contact | Larry R Pilot |
| Correspondent | Larry R Pilot MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1998-11-25 |
| Summary: | summary |