The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd with the FDA for Fetal Ultrasonic Monitor And Accessories.
| Device ID | K131457 |
| 510k Number | K131457 |
| Device Name: | FETAL ULTRASONIC MONITOR AND ACCESSORIES |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BUILDING, NANHAI BLVD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518052 |
| Contact | Field Fu |
| Correspondent | Field Fu SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BUILDING, NANHAI BLVD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518052 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2014-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055787266 | K131457 | 000 |
| 06951740520133 | K131457 | 000 |
| 06951740520140 | K131457 | 000 |
| 06951740523561 | K131457 | 000 |
| B311PEFETDPL1 | K131457 | 000 |
| 06951740500050 | K131457 | 000 |
| 06951740500067 | K131457 | 000 |
| 06951740500074 | K131457 | 000 |
| 06951740502061 | K131457 | 000 |
| 06951740502085 | K131457 | 000 |
| 00850253007086 | K131457 | 000 |
| 00850253007093 | K131457 | 000 |
| 00851908007093 | K131457 | 000 |
| 00854878007070 | K131457 | 000 |
| GYNXD25000 | K131457 | 000 |