510(k) K874726
K874726 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "MASCOT STETHOSCOPE PROBE". The FDA issued a decision of Substantially Equivalent on March 31, 1988. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1988
- Date Received
- November 18, 1987
- 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