510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PHVClass I

Continuous Glucose Monitor Retrospective Data Analysis Software

21 CFR 862.2120 / Clinical Chemistry
FDA source (opens on fda.gov)

PHV is the FDA product code for Continuous Glucose Monitor Retrospective Data Analysis Software, a class I device type, regulated under 21 CFR 862.2120. FDA's definition for this code reads: "Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PHV
Device name
Continuous Glucose Monitor Retrospective Data Analysis Software
FDA definition
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Regulation
21 CFR 862.2120
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code PHV

By decision year
1 clearance under product code PHV with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PHV by decision year
YearClearances
20141

Applicants with the most clearances

Product code PHV
Applicants holding the most 510(k) clearances under product code PHV
ApplicantClearances
Dexcom, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order