510(k) K963698
K963698 is an FDA 510(k) premarket notification submitted by International Biophysics Corp. for the device "CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4". The FDA issued a decision of Substantially Equivalent on March 20, 1997. The device falls under product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4410. International Biophysics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 1997
- Date Received
- September 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4410
- Review Panel
- CV
- Submission Type