510(k) K841996
- Device
- Maxicamera 400t W/body Contour Tomogra
- Applicant
- GENERAL ELECTRIC CO.
- 510(k) number
- K841996
- Product code
- JAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-16
- Date received
- 1984-05-16
- Regulation
- 892.1330
- Classification name
- Scanner, Whole Body, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3042278525
Source Documents#
510(k) summary PDF not indicated by FDA