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FDA 510(k), K190103, V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
FDA 510(k), K190103, V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
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$149.00 USD
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510(K) Number: K190103
Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
Manufacturer: STERIS Corporation
Device Classification Name: sterilizer, chemical
Regulation Number: 880.6860
Classification Product Code: MLR
Date Received: 01/22/2019
Decision Date: 04/05/2019
Regulation Medical Specialty: General Hospital
Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
Manufacturer: STERIS Corporation
Device Classification Name: sterilizer, chemical
Regulation Number: 880.6860
Classification Product Code: MLR
Date Received: 01/22/2019
Decision Date: 04/05/2019
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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