The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Respiratory Gas Analyzer.
| Device ID | K823449 |
| 510k Number | K823449 |
| Device Name: | RESPIRATORY GAS ANALYZER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | THORATEC LABORATORIES CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-12 |
| Decision Date | 1983-01-05 |