Cleared Traditional

STRYKER PRESSURE MONITOR SYSTEM

K883485 · Stryker Corp. · General & Plastic Surgery
Sep 1988
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K883485 is an FDA 510(k) clearance for the STRYKER PRESSURE MONITOR SYSTEM, a Tape, Measuring, Rulers And Calipers (Class I — General Controls, product code FTY), submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 13, 1988, 28 days after receiving the submission on August 16, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K883485 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1988
Decision Date September 13, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FTY — Tape, Measuring, Rulers And Calipers
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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