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 |