PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
FDA 510(k) clearance K033715 · decided 2004-02-13
Clearance details
- K-number
- K033715
- Device name
- PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-26
- Decision date
- 2004-02-13
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| M3001A Philips Multi Measurement Server (MMS) recall (Z-0183-2007) | Philips Medical Systems | 2006-11-16 |
| M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible recall (Z-0184-2007) | Philips Medical Systems | 2006-11-16 |
| IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient mo recall (Z-1487-06) | Philips Medical Systems | 2006-09-12 |