The following data is part of a premarket notification filed by Salter Labs with the FDA for Pneumatic Demand Oxygen Conserver (pdoc).
Device ID | K990678 |
510k Number | K990678 |
Device Name: | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) |
Classification | Conserver, Oxygen |
Applicant | SALTER LABS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
Contact | Duane Kazal |
Correspondent | Duane Kazal SALTER LABS 100 WEST SYCAMORE RD. 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 | 1999-03-02 |
Decision Date | 1999-05-07 |