K827409Substantially Equivalent

Real Time Ultrasound Scanner 1849

Name: K827409 Real Time Ultrasound Scanner 1849
Creator: Bruel & Kjaer Instruments, Inc.
Published: 1982-07-09
License: https://open.fda.gov/license/

Bruel & Kjaer Instruments, Inc., Marlborough MA / Traditional, Substantially Equivalent

FDA source

K827409 is the FDA 510(k) clearance record for REAL TIME ULTRASOUND SCANNER 1849, cleared for Bruel & Kjaer Instruments, Inc. on 1982-07-09. FDA records list 4 510(k) clearances for Bruel & Kjaer Instruments, Inc., from 1982-07-09 to 1991-05-31. As of 2026-09-10, FDA records show no recalls naming K827409.

Clearance record

Decision date: 1982-07-09
Received: 1982-04-30 (70 days to decision)
Review panel: Unknown
Applicant: Bruel & Kjaer Instruments, Inc. 185 Forest St., Marlborough MA
Third party review: No