Cleared Traditional

K800360 - OUTPUT DIGITAL DISPLAY MODULE, MOD. 611

K800360 is an FDA 510(k) clearance for OUTPUT DIGITAL DISPLAY MODULE, manufactured by Output, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K800360 · Output, Inc. · Cardiovascular device
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Feb 1980
Decision
9d
Days
Class 2
Risk

K800360 is an FDA 510(k) clearance for the OUTPUT DIGITAL DISPLAY MODULE, MOD. 611. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Output, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 29, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - the FDA cardiovascular device oversight framework. 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 Output, Inc. devices

FDA 510(k) Submission Details - K800360

510(k) Number K800360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date February 29, 1980
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSK Computer, Blood-pressure

All 54
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K800360.
6-415 FILTER, ELEMENT, 170-C
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MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979