510(k) K761308
- Device
- ELECTRONIC STETHOSCOPE
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K761308
- Product code
- DPD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-06
- Date received
- 1976-12-23
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA