SPIROLOOP, MODIFICATION— 510(k) K904633

Substantially Equivalent

Pneumedics, Inc.

FDA 510(k) clearance K904633 for SPIROLOOP, MODIFICATION, Substantially Equivalent on 1991-03-12. Applicant: Pneumedics, Inc.. Device class: 2.

Clearance details

Applicant: Pneumedics, Inc.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 1990-09-25
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.