The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Hr 100t.
| Device ID | K831955 |
| 510k Number | K831955 |
| Device Name: | HR 100T |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | THOUGHT TECHNOLOGY LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-17 |
| Decision Date | 1983-08-11 |