510(k) K827409
K827409 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Instruments, Inc. for the device "REAL TIME ULTRASOUND SCANNER 1849". The FDA issued a decision of Substantially Equivalent on July 9, 1982. Bruel & Kjaer Instruments, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1982
- Date Received
- April 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No