The following data is part of a premarket notification filed by Salter Labs with the FDA for Modified Demand Nasal Oxygen Cannula.
Device ID | K892407 |
510k Number | K892407 |
Device Name: | MODIFIED DEMAND NASAL OXYGEN CANNULA |
Classification | Conserver, Oxygen |
Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Contact | James N Curti |
Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-07 |
Decision Date | 1989-07-24 |