The following data is part of a premarket notification filed by Medical Taping Systems, Inc. with the FDA for Sensor Shield, Modification.
Device ID | K933755 |
510k Number | K933755 |
Device Name: | SENSOR SHIELD, MODIFICATION |
Classification | Oximeter |
Applicant | MEDICAL TAPING SYSTEMS, INC. 13 DAN DR. Glenmoore, PA 19343 |
Contact | Stephen D Solenberger |
Correspondent | Stephen D Solenberger 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 | 1993-05-05 |
Decision Date | 1994-08-16 |