TSX PRM PULMONARY RESUSCITATION MONITOR— 510(k) K973347

Name: FDA 510(k) clearance K973347
Creator: U.S. Food and Drug Administration
Published: 1998-07-23

Substantially Equivalent

Spiracle Technology

FDA 510(k) clearance K973347 for TSX PRM PULMONARY RESUSCITATION MONITOR, Substantially Equivalent on 1998-07-23. Applicant: Spiracle Technology. Device class: 2.

Clearance details

Applicant: Spiracle Technology
Product code: Code CAP
Device class: Class 2
Regulation: 21 CFR 868.2600
Advisory panel: Anesthesiology
Date received: 1997-09-05
Decision date: 1998-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Valley, CA, US

Download summary PDF View on FDA.gov ↗

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