The following data is part of a premarket notification filed by Ppg/applied Resources, Inc. with the FDA for Icu Saracap.
| Device ID | K881093 |
| 510k Number | K881093 |
| Device Name: | ICU SARACAP |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PPG/APPLIED RESOURCES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
| Contact | James F Ferguson |
| Correspondent | James F Ferguson PPG/APPLIED RESOURCES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-06-24 |