510(k) K761308
K761308 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "ELECTRONIC STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on January 6, 1977. The device falls under product code DPD (Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.), a Class II device regulated under 21 CFR 862.3320. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1977
- Date Received
- December 23, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type