The following data is part of a premarket notification filed by Hangzhou Jinlin Medical Appliances Co., Ltd. with the FDA for Kyoling Cpr Mask With Oxygen Port And Without Oxygen Port.
| Device ID | K142764 |
| 510k Number | K142764 |
| Device Name: | KYOLING CPR Mask With Oxygen Port And Without Oxygen Port |
| Classification | Valve, Non-rebreathing |
| Applicant | HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. No. 9 16TH AVE HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE Hangzhou, CN 310018 |
| Contact | Lydia He |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. 7th Floor Jingui Business Buildng No. 982 Cogyuan Rd BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-25 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10866512000245 | K142764 | 000 |
| 10866512000238 | K142764 | 000 |
| 06970856820005 | K142764 | 000 |
| 16946594904199 | K142764 | 000 |