Cleared Traditional

K791937 - ATMOS ENT PATIENT CHAIR #1 (FDA 510(k) Clearance)

K791937 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Nov 1979
Decision
47d
Days
-
Risk

K791937 is an FDA 510(k) clearance for the ATMOS ENT PATIENT CHAIR #1.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K791937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1979
Decision Date November 13, 1979
Days to Decision 47 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 89d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETL
Device Class -