510(k) K771520
K771520 is an FDA 510(k) premarket notification submitted by Labarge, Inc. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on September 23, 1977. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Labarge, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1977
- Date Received
- August 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type