The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Respiratory Assessment System.
| Device ID | K833714 |
| 510k Number | K833714 |
| Device Name: | RESPIRATORY ASSESSMENT SYSTEM |
| Classification | Computer, Oxygen-uptake |
| Applicant | THORATEC LABORATORIES CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-21 |
| Decision Date | 1983-12-29 |