Cleared Traditional

K837029 - ECHOSINE 1000

K837029 · American Electromedics Corp. · Radiology device
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Mar 1983
Decision
102d
Days
-
Risk

K837029 is an FDA 510(k) clearance for the ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE.

Submitted by American Electromedics Corp. (Hudson, US). The FDA issued a Cleared decision on March 22, 1983 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Electromedics Corp. devices

FDA 510(k) Submission Details - K837029

510(k) Number K837029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date March 22, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -