510(k) K860994
K860994 is an FDA 510(k) premarket notification submitted by Bloomfield Research and Development, Inc. for the device "DECITEL AUSCULSCOPE". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Bloomfield Research and Development, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1986
- Date Received
- March 17, 1986
- 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