The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd. with the FDA for Pulse Oximeter, Models Pc-66a; Pc-66b; Pc-66c;pc-60b1; Pc-60b5; Pc-60d; Pc-60d2; Pc-60e; Pc-60n; Pod-1; Pod-2; Pod-3; Pc-68a; Pc-68b; Pc-68c; Pod- 1w; And Pod-60nw-1.
| Device ID | K150093 |
| 510k Number | K150093 |
| Device Name: | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; And POD-60NW-1 |
| Classification | Oximeter |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD. 2/F, BLOCK 3, NANYOU TIAN'AN INDUSTRY TOWN Shenzhen City, CN 518054 |
| Contact | Jia Wang |
| Correspondent | Charles Mack IRC 12226 WASHINGTON LANE Parker, AZ 85344 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-16 |
| Decision Date | 2015-06-03 |
| Summary: | summary |