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.
Device ID | K151506 |
510k Number | K151506 |
Device Name: | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula |
Classification | Conserver, Oxygen |
Applicant | Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
Contact | Mara Caler |
Correspondent | Mara Caler Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-04 |
Decision Date | 2016-03-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |