510(k) K780510
- Device
- Nuclear Stethoscope
- Applicant
- BIOS, INC.
- 510(k) number
- K780510
- Product code
- IYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-18
- Date received
- 1978-03-30
- Regulation
- 892.1410
- Classification name
- Synchronizer, Electrocardiograph, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA