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 |