The following data is part of a premarket notification filed by Medical Taping Systems, Inc. with the FDA for Sensor Shield.
| Device ID | K910811 | 
| 510k Number | K910811 | 
| Device Name: | SENSOR SHIELD | 
| Classification | Oximeter | 
| Applicant | MEDICAL TAPING SYSTEMS, INC. 13 DAN DR. Glenmoore, PA 19343 | 
| Contact | Stephen D Solenberg | 
| Correspondent | Stephen D Solenberg MEDICAL TAPING SYSTEMS, INC. 13 DAN DR. Glenmoore, PA 19343 | 
| Product Code | DQA | 
| CFR Regulation Number | 870.2700 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1991-02-26 | 
| Decision Date | 1992-12-23 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SENSOR SHIELD  98772718  not registered Live/Pending | Sensor Shield Inc. 2024-09-26 |