510(k) K900574
K900574 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "ABIOMED BODY LEAD ANALYZER MODEL 200/20". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code JAO (Scanner, Fluorescent), a Class II device regulated under 21 CFR 892.1220. Abiomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1990
- Date Received
- February 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Fluorescent
- Device Class
- Class II
- Regulation Number
- 892.1220
- Review Panel
- RA
- Submission Type