The following data is part of a premarket notification filed by Foshan Care Medical Technology Co., Ltd. with the FDA for Foshan Care Medical Nebulizer Model Kywh2001.
| Device ID | K101552 |
| 510k Number | K101552 |
| Device Name: | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. 4807 EL CAMINO AVE STE C Carmichael, CA 95608 |
| Contact | S.david Piper, Pe |
| Correspondent | S.david Piper, Pe FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. 4807 EL CAMINO AVE STE C Carmichael, CA 95608 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2011-03-14 |