The following data is part of a premarket notification filed by Sensor Medical Technology, Llc with the FDA for Sensor Medical Single Use Tonometer Prism.
| Device ID | K152308 |
| 510k Number | K152308 |
| Device Name: | Sensor Medical Single Use Tonometer Prism |
| Classification | Tonometer, Manual |
| Applicant | SENSOR MEDICAL TECHNOLOGY, LLC 23175 224th Place SE Maple Valley, WA 98038 |
| Contact | Louise Culham |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2015-10-13 |
| Summary: | summary |