TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
FDA 510(k) clearance K032291 · decided 2004-08-24
Clearance details
- K-number
- K032291
- Device name
- TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
- Applicant
- Linde Medical Sensors AG
- Decision
- Substantially Equivalent
- Date received
- 2003-07-24
- Decision date
- 2004-08-24
- Days to decision
- 397 days
- Clearance type
- Traditional
- Product code
- DOA
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.