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FDA 510(k), K110064, SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
FDA 510(k), K110064, SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
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510(K) Number: K110064
Device Name: SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
Manufacturer: GIL RAVIV
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: MNR
Classification Product Code: KXA
Date Received: 01/10/2011
Decision Date: 03/18/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
Manufacturer: GIL RAVIV
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: MNR
Classification Product Code: KXA
Date Received: 01/10/2011
Decision Date: 03/18/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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