K072235 is an FDA 510(k) clearance for the PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR. 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 October 19, 2007, 70 days after receiving the submission on August 10, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K072235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2007 |
| Decision Date | October 19, 2007 |
| Days to Decision | 70 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 |