The following data is part of a premarket notification filed by Team Innovations, Inc with the FDA for Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes.
| Device ID | K101576 |
| 510k Number | K101576 |
| Device Name: | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | TEAM INNOVATIONS, INC 2521 SOUTH 98 STREET West Allis, WI 53227 |
| Contact | Mark Tiegs |
| Correspondent | Mark Tiegs TEAM INNOVATIONS, INC 2521 SOUTH 98 STREET West Allis, WI 53227 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867972000250 | K101576 | 000 |