Cleared Traditional

INTERMITTENT COMPRESSION SYSTEM MODEL 5000

K930526 · Advanced Instruments, Inc. · Cardiovascular
Nov 1993
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K930526 is an FDA 510(k) clearance for the INTERMITTENT COMPRESSION SYSTEM MODEL 5000, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Advanced Instruments, Inc. (Norwood, US). The FDA issued a Cleared decision on November 18, 1993, 289 days after receiving the submission on February 2, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K930526 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1993
Decision Date November 18, 1993
Days to Decision 289 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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