The following data is part of a premarket notification filed by Salter Labs with the FDA for Oxygen Conservator.
Device ID | K863657 |
510k Number | K863657 |
Device Name: | OXYGEN CONSERVATOR |
Classification | Flowmeter, Nonback-pressure Compensated, Bourdon Gauge |
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 | CCN |
CFR Regulation Number | 868.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-18 |
Decision Date | 1986-10-15 |