Cleared Traditional

K803104 - MICROWAVE OVEN 2M9810 (FDA 510(k) Clearance)

K803104 · Travenol Laboratories, S.A. · General Hospital
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Apr 1981
Decision
136d
Days
-
Risk

K803104 is an FDA 510(k) clearance for the MICROWAVE OVEN 2M9810.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1981 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General Hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K803104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1980
Decision Date April 24, 1981
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 128d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -