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FDA 510(k), K173929, CipherOx CRI M1
FDA 510(k), K173929, CipherOx CRI M1
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510(K) Number: K173929
Device Name: CipherOx CRI M1
Manufacturer: Gregory Z. Grudic
Device Classification Name: Adjunctive Cardiovascular Status Indicator
Regulation Number: PPW
Classification Product Code: 12/26/2017
Date Received: 07/24/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CipherOx CRI M1
Manufacturer: Gregory Z. Grudic
Device Classification Name: Adjunctive Cardiovascular Status Indicator
Regulation Number: PPW
Classification Product Code: 12/26/2017
Date Received: 07/24/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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