The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Pulse Oximeter, Model Pm-50.
| Device ID | K061442 |
| 510k Number | K061442 |
| Device Name: | PULSE OXIMETER, MODEL PM-50 |
| Classification | Oximeter |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2006-09-05 |
| Summary: | summary |