The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Respiratory Flow Module.
| Device ID | K833265 |
| 510k Number | K833265 |
| Device Name: | RESPIRATORY FLOW MODULE |
| Classification | Pneumotachometer |
| Applicant | THORATEC LABORATORIES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1983-11-28 |