Cleared Traditional

ESCORT SPIROMETER

K925085 · Vitalograph , Ltd. · Anesthesiology
Aug 1993
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K925085 is an FDA 510(k) clearance for the ESCORT SPIROMETER, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on August 12, 1993, 309 days after receiving the submission on October 7, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K925085 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1992
Decision Date August 12, 1993
Days to Decision 309 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840