PACER MODEL 100 INFUSION CONTROLLER— 510(k) K963136

Name: FDA 510(k) clearance K963136
Creator: U.S. Food and Drug Administration
Published: 1997-10-10

Substantially Equivalent

Health Watch, Inc.

FDA 510(k) clearance K963136 for PACER MODEL 100 INFUSION CONTROLLER, Substantially Equivalent on 1997-10-10. Applicant: Health Watch, Inc.. Device class: 2.

Clearance details

Applicant: Health Watch, Inc.
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1996-08-13
Decision date: 1997-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, US

Download summary PDF View on FDA.gov ↗

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