K900574 is an FDA 510(k) clearance for the ABIOMED BODY LEAD ANALYZER MODEL 200/20. This device is classified as a Scanner, Fluorescent (Class II - Special Controls, product code JAO).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on March 15, 1990, 36 days after receiving the submission on February 7, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1220.
| 510(k) Number | K900574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1990 |
| Decision Date | March 15, 1990 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | JAO - Scanner, Fluorescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1220 |