510(k) K830149
K830149 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-". The FDA issued a decision of Substantially Equivalent on February 28, 1983. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1983
- Date Received
- January 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suction Control, Intracardiac, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4430
- Review Panel
- CV
- Submission Type