K061442 is an FDA 510(k) clearance for the PULSE OXIMETER, MODEL PM-50. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 5, 2006, 104 days after receiving the submission on May 24, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K061442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2006 |
| Decision Date | September 05, 2006 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |