510(k) K854045
K854045 is an FDA 510(k) premarket notification submitted by American Bentley for the device "MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED". The FDA issued a decision of Substantially Equivalent on December 16, 1985. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. American Bentley has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1985
- Date Received
- October 2, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type