The following data is part of a premarket notification filed by Wipro Ge Healthcare with the FDA for Mac 2000 Ecg Analysis System.
| Device ID | K133622 |
| 510k Number | K133622 |
| Device Name: | MAC 2000 ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | WIPRO GE HEALTHCARE 8200 WEST TOWER AVE Milwauki, WI 53223 |
| Contact | Douglas Kentz |
| Correspondent | Douglas Kentz WIPRO GE HEALTHCARE 8200 WEST TOWER AVE Milwauki, WI 53223 |
| Product Code | DPS |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-22 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682105071 | K133622 | 000 |