Cleared Traditional

APM DISPOS. BLOOD PRESSURE TRANSDUCER

K851888 · Honeywell, Inc. · Cardiovascular
Aug 1985
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K851888 is an FDA 510(k) clearance for the APM DISPOS. BLOOD PRESSURE TRANSDUCER, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on August 6, 1985, 97 days after receiving the submission on May 1, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number K851888 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1985
Decision Date August 06, 1985
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRS — Transducer, Blood-pressure, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2850

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