The following data is part of a premarket notification filed by Sky Wise Medical Instrument (shen Zhen) Co., Ltd. with the FDA for Skynector Cpap Mask.
| Device ID | K150685 |
| 510k Number | K150685 |
| Device Name: | Skynector CPAP Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. NO.12 SOUTH PING XI RD XINSHENG COMMUNITY, LONGGANG ST. LONGGANG DIST Shenzhen, Guang Dong, CN 518110 |
| Contact | Field Fu |
| Correspondent | Field Fu SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. NO.12 SOUTH PING XI RD XINSHENG COMMUNITY, LONGGANG ST. LONGGANG DIST Shenzhen, Guang Dong, CN 518110 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-17 |
| Decision Date | 2015-08-24 |
| Summary: | summary |