Cleared Traditional

INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04

K933278 · Intermedics, Inc. · Cardiovascular
Mar 1995
Decision
624d
Days
Class 3
Risk

About This 510(k) Submission

K933278 is an FDA 510(k) clearance for the INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on March 15, 1995, 624 days after receiving the submission on June 29, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number K933278 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1993
Decision Date March 15, 1995
Days to Decision 624 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRG — Programmer, Pacemaker
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3700

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