The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Cm02 Cuvette, 1/2, Cm02 Cuvette, 3/8 And Cm02 Cuvette, 1/4.
Device ID | K963698 |
510k Number | K963698 |
Device Name: | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 |
Classification | Sensor, Blood-gas, In-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 | DTY |
CFR Regulation Number | 870.4410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-16 |
Decision Date | 1997-03-20 |
Summary: | summary |