KOKO PEAK KP; KOKO PEAK KP+— 510(k) K010009

Name: FDA 510(k) clearance K010009
Creator: U.S. Food and Drug Administration
Published: 2001-06-01

Substantially Equivalent

Pds Healthcare Products, Inc.

FDA 510(k) clearance K010009 for KOKO PEAK KP; KOKO PEAK KP+, Substantially Equivalent on 2001-06-01. Applicant: Pds Healthcare Products, Inc.. Device class: 2.

Clearance details

Applicant: Pds Healthcare Products, Inc.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2001-01-02
Decision date: 2001-06-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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