PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
FDA 510(k) clearance K072235 · decided 2007-10-19
Clearance details
- K-number
- K072235
- Device name
- PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-10
- Decision date
- 2007-10-19
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, recall (Z-1397-2010) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2010-04-15 |
| SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahwa recall (Z-1398-2010) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2010-04-15 |