The following data is part of a premarket notification filed by Zhengzhou Bestview St Co., Ltd. with the FDA for Co2 Laser Machine, Model: Bw-203b.
Device ID | K211735 |
510k Number | K211735 |
Device Name: | CO2 Laser Machine, Model: BW-203B |
Classification | Powered Laser Surgical Instrument |
Applicant | Zhengzhou Bestview St Co., Ltd. Room 2004, 20F, Lande Center, Huayuan Road, Jinshui District Zhengzhou, CN 450000 |
Contact | Yangchun Jia |
Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-07 |
Decision Date | 2021-10-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06974892092013 | K211735 | 000 |
06974851082017 | K211735 | 000 |