The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Quick Cell Component (1/2, 3/8, 1/4).
| Device ID | K955380 |
| 510k Number | K955380 |
| Device Name: | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| 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 | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1996-05-14 |
| Summary: | summary |