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FDA 510(k), K124059, AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
FDA 510(k), K124059, AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
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510(K) Number: K124059
Device Name: AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
Manufacturer: STEPHAN KRIETEMEYER
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: 12/31/2012
Date Received: 03/25/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
Manufacturer: STEPHAN KRIETEMEYER
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: 12/31/2012
Date Received: 03/25/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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