PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS— 510(k) K951246

Name: FDA 510(k) clearance K951246
Creator: U.S. Food and Drug Administration
Published: 1996-02-02

Substantially Equivalent - Subject to Tracking Reg.

Protocol Systems, Inc.

FDA 510(k) clearance K951246 for PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS, Substantially Equivalent - Subject to Tracking Reg. on 1996-02-02. Applicant: Protocol Systems, Inc.. Device class: 2.

Clearance details

Applicant: Protocol Systems, Inc.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1995-03-20
Decision date: 1996-02-02
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Beaverton, OR, US

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