PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE
FDA 510(k) clearance K081937 · decided 2008-08-29
Clearance details
- K-number
- K081937
- Device name
- PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-07-07
- Decision date
- 2008-08-29
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Bw, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.