Cleared Traditional

K837029 - ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE (FDA 510(k) Clearance)

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

Submission Details

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

Product Code -
Device Class -