The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Hysteroscope System.
| Device ID | K181545 |
| 510k Number | K181545 |
| Device Name: | Hysteroscope System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Shanghai AnQing Medical Instrument CO., Ltd. 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, CN 201210 |
| Contact | Lina Fei |
| Correspondent | Lina Fei Shanghai AnQing Medical Instrument CO., Ltd. 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, CN 201210 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-12 |
| Decision Date | 2019-05-10 |