DeviceClearance

NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN— 510(k) K123766

Substantially Equivalent

Novo Nordisk, Inc.

FDA 510(k) clearance K123766 for NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN, Substantially Equivalent on 2013-08-15. Applicant: Novo Nordisk, Inc.. Device class: 2.

Clearance details

Applicant
Novo Nordisk, Inc.
Product code
Code FMF
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plainsboro, NJ, US
Download summary PDFView on FDA.gov ↗

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More clearances from Novo Nordisk, Inc.

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Adverse events under product code FMF

product code FMF
Death
15
Injury
2,263
Malfunction
29,722
Other
17
Total
32,017

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 K123766

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 K123766.

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