DeviceClearance

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)— 510(k) K153193

Substantially Equivalent

Zyno Medical, LLC

FDA 510(k) clearance K153193 for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System), Substantially Equivalent on 2016-08-30. Applicant: Zyno Medical, LLC. Device class: 2.

Clearance details

Applicant
Zyno Medical, LLC
Product code
Code FRN
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Natick, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K153193

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153193.

Data sourced from openFDA. This site is unofficial and independent of the FDA.