Cleared Traditional

VITALOGRAPH-ALPHA

K873562 · Vitalograph , Ltd. · Anesthesiology
Aug 1988
Decision
362d
Days
Class 2
Risk

About This 510(k) Submission

K873562 is an FDA 510(k) clearance for the VITALOGRAPH-ALPHA, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on August 29, 1988, 362 days after receiving the submission on September 2, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K873562 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1987
Decision Date August 29, 1988
Days to Decision 362 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

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