510(k) K991756
K991756 is an FDA 510(k) premarket notification submitted by Bio-Research Associates, Inc. for the device "3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on December 10, 1999. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Bio-Research Associates, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1999
- Date Received
- May 24, 1999
- 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