Cleared Traditional

K832356 - PORTABLE OPERAT. RM. MONITORS HS30/40 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K832356 · Medtel Pty. , Ltd. · Anesthesiology device
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Oct 1983
Decision
102d
Days
Class 1
Risk

K832356 is an FDA 510(k) clearance for the PORTABLE OPERAT. RM. MONITORS HS30/40. Classified as Cart, Emergency, Cardiopulmonary (excluding Equipment) (product code BZN), Class I - General Controls.

Submitted by Medtel Pty. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6175 - the FDA anesthesiology and respiratory device framework. 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtel Pty. , Ltd. devices

Submission Details

510(k) Number K832356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date October 28, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 139d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZN Cart, Emergency, Cardiopulmonary (excluding Equipment)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.