Product code NPF— Anesthesiology

SMARTMONITOR 2 PROFESSIONAL SERIES (PS)

Classification name: Monitor, Apnea, Home Use
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Total cleared: 2
First cleared: 2003-10-27
Most recent: 2006-08-02

FDA classification definition

“Same as the identification for product code FLS, just add home use”
— U.S. Food and Drug Administration, device classification record for product code NPF under 21 CFR 868.2377, via openFDA

Market context for product code NPF

FDA has cleared 2 devices under product code NPF between 2003 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20061 clearance
20031 clearance

Top applicants under product code NPF

Respironics, Inc.2 clearances

Recent clearances under product code NPF

K061256 — SMARTMONITOR 2PSRespironics, Inc.·2006-08-02
K032403 — SMARTMONITOR 2 PROFESSIONAL SERIES (PS)Respironics, Inc.·2003-10-27

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