The following data is part of a premarket notification filed by Mianyang Meike Electronic Equipment Co., Ltd. with the FDA for Palm Bladder Scanner.
| Device ID | K130229 |
| 510k Number | K130229 |
| Device Name: | PALM BLADDER SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
| Contact | Helen Nan |
| Correspondent | Helen Nan MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06940912714012 | K130229 | 000 |