The following data is part of a premarket notification filed by Foshan Care Medical Technology Co., Ltd. with the FDA for Care Zy5ba Oxygen Concentrator.
| Device ID | K102245 |
| 510k Number | K102245 |
| Device Name: | CARE ZY5BA OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. KEJIMAN 12 ROAD, HI-TEC IND PK HUATONGWEI BLDG Nanshan, Shenzhen, CN 518057 |
| Contact | Kathy Guo |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971072050115 | K102245 | 000 |