DISPOSABLE INCENTIVE SPIROMETER— 510(k) K781394

Name: FDA 510(k) clearance K781394
Creator: U.S. Food and Drug Administration
Published: 1978-10-16

Substantially Equivalent

Inhal-O-Tech Medical Plastic

FDA 510(k) clearance K781394 for DISPOSABLE INCENTIVE SPIROMETER, Substantially Equivalent on 1978-10-16. Applicant: Inhal-O-Tech Medical Plastic. Device class: 1.

Clearance details

Applicant: Inhal-O-Tech Medical Plastic
Product code: Code CCQ
Device class: Class 1
Regulation: 21 CFR 868.5640
Advisory panel: Anesthesiology
Date received: 1978-08-14
Decision date: 1978-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

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K770353 — DISPOSABLE TEMPERATURE PROBE1977-03-16
K770354 — TUBING, AEROSAL, DISPOSABLE1977-03-16
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