Cleared Traditional

K841048 - TRANSDUCER 4.OMHZ LA4011 (FDA 510(k) Clearance)

Jan 1985
Decision
319d
Days
-
Risk

K841048 is an FDA 510(k) clearance for the TRANSDUCER 4.OMHZ LA4011..

Submitted by Philips Ultrasound, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 25, 1985, 319 days after receiving the submission on March 12, 1984.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K841048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date January 25, 1985
Days to Decision 319 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -

Device Classification

Product Code -
Device Class -