SPIROLOOP-PULMONARY EXERCISE SYSTEM— 510(k) K863087

Name: FDA 510(k) clearance K863087
Creator: U.S. Food and Drug Administration
Published: 1986-10-27

Substantially Equivalent

Pneumedics, Inc.

FDA 510(k) clearance K863087 for SPIROLOOP-PULMONARY EXERCISE SYSTEM, Substantially Equivalent on 1986-10-27. Applicant: Pneumedics, Inc.. Device class: 2.

Clearance details

Applicant: Pneumedics, Inc.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1986-08-12
Decision date: 1986-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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