The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Sentry Radiotranslucent Ecg Electrodes.
| Device ID | K962122 |
| 510k Number | K962122 |
| Device Name: | SENTRY RADIOTRANSLUCENT ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Contact | James G Strokes |
| Correspondent | James G Strokes SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-07-24 |