Cleared Traditional

HM-SPIRO

K951718 · Hill-Med, Inc. · Anesthesiology
Dec 1995
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K951718 is an FDA 510(k) clearance for the HM-SPIRO, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Hill-Med, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 20, 1995, 251 days after receiving the submission on April 13, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K951718 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1995
Decision Date December 20, 1995
Days to Decision 251 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