510(k) K781152
- Device
- Electrocardiographic Ecg Recorder
- Applicant
- CARDIO-DYNAMICS LABORATORIES, INC.
- 510(k) number
- K781152
- Product code
- DSM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-31
- Date received
- 1978-07-10
- Regulation
- 870.2640
- Classification name
- Alarm, Leakage Current, Portable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2436826
Source Documents#
510(k) summary PDF not indicated by FDA