The following data is part of a premarket notification filed by Gri Medical & Electronic Technology Co, Ltd with the FDA for Gentleheel Micro-preemie, Gentleheel Preemie, Gentleheel Newborn, Gentleheel Toddler.
| Device ID | K172712 |
| 510k Number | K172712 |
| Device Name: | Gentleheel Micro-Preemie, Gentleheel Preemie, Gentleheel Newborn, Gentleheel Toddler |
| Classification | Lancet, Blood |
| Applicant | GRI Medical & Electronic Technology Co, Ltd XiuZhou Industry Zone, 1805 Honggao Road Jiaxing, CN 314031 |
| Contact | Marty D. Paugh |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, GA 30004 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2017-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380024687 | K172712 | 000 |
| 26931918136933 | K172712 | 000 |
| 26931918164783 | K172712 | 000 |
| 26931918196531 | K172712 | 000 |
| 20885380024631 | K172712 | 000 |
| 20885380024648 | K172712 | 000 |
| 50885380024663 | K172712 | 000 |
| 20885380024679 | K172712 | 000 |
| 20885380024693 | K172712 | 000 |
| 20885380028110 | K172712 | 000 |
| 50885380024656 | K172712 | 000 |
| 26931918128938 | K172712 | 000 |