The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Abiomed Body Lead Analyzer Model 200/20.
| Device ID | K900574 |
| 510k Number | K900574 |
| Device Name: | ABIOMED BODY LEAD ANALYZER MODEL 200/20 |
| Classification | Scanner, Fluorescent |
| Applicant | ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Fredric L Milder |
| Correspondent | Fredric L Milder ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | JAO |
| CFR Regulation Number | 892.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-03-15 |