The following data is part of a premarket notification filed by Bio Medical Technologies Co., Ltd with the FDA for Oxiprobe E (oxiprobe).
| Device ID | K132516 |
| 510k Number | K132516 |
| Device Name: | OXIPROBE E (OXIPROBE) |
| Classification | Oximeter |
| Applicant | BIO MEDICAL TECHNOLOGIES CO., LTD P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BIO MEDICAL TECHNOLOGIES CO., LTD P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2014-07-30 |
| Summary: | summary |