Cleared Traditional

K830795 - CABINET FOR MULTIPLE FUNCTION BLOCKS

K830795 is the FDA 510(k) clearance for CABINET FOR MULTIPLE FUNCTION BLOCKS by Electronics For Medicine, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K830795 · Electronics For Medicine, Inc. · Cardiovascular device
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May 1983
Decision
65d
Days
Class 2
Risk

K830795 is an FDA 510(k) clearance for the CABINET FOR MULTIPLE FUNCTION BLOCKS. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Electronics For Medicine, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Electronics For Medicine, Inc. devices

Submission Details

510(k) Number K830795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date May 18, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 92
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K830795.
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MODEL 78534A PATIENT MONITOR
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