510(k) K993060
K993060 is an FDA 510(k) premarket notification submitted by Olson Medical Sales, Inc. for the device "GAS FILTER". The FDA issued a decision of Substantially Equivalent on March 28, 2000. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Olson Medical Sales, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2000
- Date Received
- September 13, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4270
- Review Panel
- CV
- Submission Type