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

Mountain View, CA, US

Livongo Health, Inc. appears in FDA device records in Mountain View, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Livongo Health, Inc. in 2020.

Clearances by year, as a table
510(k) clearance decisions for Livongo Health, Inc., by decision year
YearClearances
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200277Livongo Blood Glucose Monitoring System (BG1000)NBWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1587-2016The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acidClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain