The following data is part of a premarket notification filed by Bio Medical Technologies Co., Ltd with the FDA for Oxiprobe, Models Bm-100, Bm-200, Bm-400, Bm-300, Bm-300s, Bm-600p.
| Device ID | K092549 |
| 510k Number | K092549 |
| Device Name: | OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P |
| Classification | Oximeter |
| Applicant | BIO MEDICAL TECHNOLOGIES CO., LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Contact | Cathryn Cambria |
| Correspondent | Cathryn Cambria BIO MEDICAL TECHNOLOGIES CO., LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-11-16 |
| Summary: | summary |