The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Flopump, Model 6000.
| Device ID | K983272 |
| 510k Number | K983272 |
| Device Name: | IBC FLOPUMP, MODEL 6000 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Contact | H. David Shockley, Jr |
| Correspondent | H. David Shockley, Jr INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1999-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814321020124 | K983272 | 000 |
| 00814321020117 | K983272 | 000 |
| 00814321020100 | K983272 | 000 |
| 00814321020094 | K983272 | 000 |
| 00814321020018 | K983272 | 000 |
| 00814321020001 | K983272 | 000 |
| 00814321020452 | K983272 | 000 |