The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs #4001 Oral Nasal Co2 Sampling Cannula.
| Device ID | K864199 |
| 510k Number | K864199 |
| Device Name: | SALTER LABS #4001 ORAL NASAL CO2 SAMPLING 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 | 1986-10-27 |
| Decision Date | 1987-02-10 |