KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M— 510(k) K981260

Substantially Equivalent

Clinical Innovations, Inc.

FDA 510(k) clearance K981260 for KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M, Substantially Equivalent on 1998-09-22. Applicant: Clinical Innovations, Inc..

Clearance details

Applicant
Clinical Innovations, Inc.
Product code
Code HDB
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Murray, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HDB

product code HDB
Death
7
Total
7

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 →

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