The following data is part of a premarket notification filed by Wipro Ge Healthcare Private, Ltd. with the FDA for Mini Telemetry System.
| Device ID | K110556 |
| 510k Number | K110556 |
| Device Name: | MINI TELEMETRY SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GOMAN ROAD Laurel, MD 20723 -5800 |
| Contact | Agata Smieja |
| Correspondent | Agata Smieja WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GOMAN ROAD Laurel, MD 20723 -5800 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682117166 | K110556 | 000 |
| 00840682117128 | K110556 | 000 |
| 00840682117067 | K110556 | 000 |
| 00840682117012 | K110556 | 000 |
| 00840682116992 | K110556 | 000 |
| 00840682117173 | K110556 | 000 |
| 00840682117111 | K110556 | 000 |
| 00840682117081 | K110556 | 000 |