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

Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)

21 CFR 868.1500 / Anesthesiology
FDA source (opens on fda.gov)

NHP is the FDA product code for Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration), a class II device type, regulated under 21 CFR 868.1500. FDA's definition for this code reads: "A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NHP
Device name
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
FDA definition
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Regulation
21 CFR 868.1500
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NHP

By decision year
1 clearance under product code NHP with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NHP by decision year
YearClearances
20041

Applicants with the most clearances

Product code NHP
Applicants holding the most 510(k) clearances under product code NHP
ApplicantClearances
Draeger Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order