510(k) K900574
- Device
- ABIOMED BODY LEAD ANALYZER MODEL 200/20
- Applicant
- ABIOMED, INC.
- 510(k) number
- K900574
- Product code
- JAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-15
- Date received
- 1990-02-07
- Regulation
- 892.1220
- Classification name
- Scanner, Fluorescent
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FREDRIC L MILDER
- Address
- 33 Cherry Hill Dr. Danvers MA US 01923 01923
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911749 | L-LINEX-RAY FLUORESCENCE | Montifore Medical Center | 1991-08-20 |
Legacy Summary#
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FDA Review#
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