510(k) K770530
- Device
- CLEON IMAGER
- Applicant
- Union Carbide Corp.
- 510(k) number
- K770530
- Product code
- JAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-05
- Date received
- 1977-03-21
- Regulation
- 892.1330
- Classification name
- Scanner, Whole Body, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3042278525
Source Documents#
510(k) summary PDF not indicated by FDA