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FDA 510(k), K111933, COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
FDA 510(k), K111933, COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
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510(K) Number: K111933
Device Name: COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
Manufacturer: COVIDIEN
Device Classification Name: monitor, breathing frequency
Regulation Number: 868.2375
Classification Product Code: BZQ
Date Received: 07/08/2011
Decision Date: 03/15/2012
Regulation Medical Specialty: Anesthesiology
Device Name: COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
Manufacturer: COVIDIEN
Device Classification Name: monitor, breathing frequency
Regulation Number: 868.2375
Classification Product Code: BZQ
Date Received: 07/08/2011
Decision Date: 03/15/2012
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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