The following data is part of a premarket notification filed by Wipro Ge Healthcare Private, Ltd. with the FDA for 1.5t 4ch Large Flex Coil, 1.5 4ch Small Flex Coil.
| Device ID | K123681 |
| 510k Number | K123681 |
| Device Name: | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | WIPRO GE HEALTHCARE PRIVATE, LTD. 122 (PART 1) JOHN F WELCH TRDNG CENTRE, EPIP, WHITEFIELD RD Bangalore, IN 560066 |
| Contact | Shashidhar C S |
| Correspondent | Shashidhar C S WIPRO GE HEALTHCARE PRIVATE, LTD. 122 (PART 1) JOHN F WELCH TRDNG CENTRE, EPIP, WHITEFIELD RD Bangalore, IN 560066 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-30 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118606 | K123681 | 000 |
| 00840682118576 | K123681 | 000 |