The following data is part of a premarket notification filed by Salter Labs with the FDA for Models 4002/4102/4202 Oxy. Delivery/co2 Cannula.
| Device ID | K863883 |
| 510k Number | K863883 |
| Device Name: | MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA |
| 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 | 1986-10-06 |
| Decision Date | 1986-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517062247 | K863883 | 000 |
| 35019517062230 | K863883 | 000 |
| 35019517062223 | K863883 | 000 |
| 35019517062216 | K863883 | 000 |
| 35019517054228 | K863883 | 000 |
| 35019517053955 | K863883 | 000 |
| 35019517053924 | K863883 | 000 |
| 35019517053894 | K863883 | 000 |