510(k) K955380
K955380 is an FDA 510(k) premarket notification submitted by International Biophysics Corp. for the device "IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)". The FDA issued a decision of Substantially Equivalent on May 14, 1996. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. International Biophysics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1996
- Date Received
- November 24, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type