SMARTMONITOR 2PS— 510(k) K061256

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K061256 for SMARTMONITOR 2PS, Substantially Equivalent on 2006-08-02. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code NPF
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 2006-05-04
Decision date: 2006-08-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPF

K032403 — SMARTMONITOR 2 PROFESSIONAL SERIES (PS)2003-10-27

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Recalls naming K061256

K-number listed on FDA's recall record

Z-2250-2017 — SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.Class II·Terminated·Circadiance LLC·20170501
Z-1789-2014 — Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.Class II·Terminated·Childrens Medical Ventures·20140429

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061256.

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