The following data is part of a premarket notification filed by Acare Technology Co., Ltd. with the FDA for Pulse Oximeter Model Ab-f1/ah-s1/ah-m1.
| Device ID | K111617 |
| 510k Number | K111617 |
| Device Name: | PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 |
| Classification | Oximeter |
| Applicant | ACARE TECHNOLOGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong ACARE TECHNOLOGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-10 |
| Decision Date | 2011-12-22 |