510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NPFClass II

Monitor, Apnea, Home Use

21 CFR 868.2377 / Anesthesiology
FDA source (opens on fda.gov)

NPF is the FDA product code for Monitor, Apnea, Home Use, a class II device type, regulated under 21 CFR 868.2377. FDA's definition for this code reads: "Same as the identification for product code FLS, just add home use". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NPF
Device name
Monitor, Apnea, Home Use
FDA definition
Same as the identification for product code FLS, just add home use
Regulation
21 CFR 868.2377
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
3

Clearances, product code NPF

By decision year
2 clearances under product code NPF with a decision year between 2003 and 2006, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NPF by decision year
YearClearances
20031
20061

Applicants with the most clearances

Product code NPF
Applicants holding the most 510(k) clearances under product code NPF
ApplicantClearances
Respironics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code