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

Apparatus, Nitric Oxide, Backup Delivery

21 CFR 868.5165 / Anesthesiology
FDA source (opens on fda.gov)

MRO is the FDA product code for Apparatus, Nitric Oxide, Backup Delivery, a class II device type, regulated under 21 CFR 868.5165. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MRO
Device name
Apparatus, Nitric Oxide, Backup Delivery
Regulation
21 CFR 868.5165
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
4
Ingested recalls
0

Clearances, product code MRO

By decision year
4 clearances under product code MRO with a decision year between 2001 and 2012, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MRO by decision year
YearClearances
20012
20051
20121

Applicants with the most clearances

Product code MRO
Applicants holding the most 510(k) clearances under product code MRO
ApplicantClearances
Fadasis Medical, Inc.2
Mallinckrodt Manufacturing LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code