The following data is part of a premarket notification filed by Salter Labs with the FDA for Mod. 4003 Adu., Oxy. Delive.-oral/nasal Co2 Cannu..
| Device ID | K864902 |
| 510k Number | K864902 |
| Device Name: | MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586038260 | K864902 | 000 |