Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

Conserver, Oxygen

Salter Labs

The following data is part of a premarket notification filed by Salter Labs with the FDA for Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula.

Pre-market Notification Details

Device IDK151506
510k NumberK151506
Device Name:Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
ClassificationConserver, Oxygen
Applicant Salter Labs 2365 Camino Vida Roble Carlsbad,  CA  92011
ContactMara Caler
CorrespondentMara Caler
Salter Labs 2365 Camino Vida Roble Carlsbad,  CA  92011
Product CodeNFB  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-04
Decision Date2016-03-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
01060741194061 K151506 000
10607411301473 K151506 000
20607411400630 K151506 000
10607411400671 K151506 000
10607411400688 K151506 000
10607411400824 K151506 000
10607411400879 K151506 000
10607411400886 K151506 000
10607411889490 K151506 000
00607411889721 K151506 000
00607411889813 K151506 000
00607411891687 K151506 000
10607411891691 K151506 000
10607411891707 K151506 000
10607411940665 K151506 000
10607411007986 K151506 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.