K831955 is an FDA 510(k) clearance for the HR 100T. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Thought Technology , Ltd. (Walker, US). The FDA issued a Cleared decision on August 11, 1983, 55 days after receiving the submission on June 17, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K831955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | JOM — Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2780 |