ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK— 510(k) K102648

Substantially Equivalent

Shenzhen Ant Hi-Tech Industrial Co., Ltd.

FDA 510(k) clearance K102648 for ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK, Substantially Equivalent on 2011-07-01. Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd..

Clearance details

Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2010-09-14
Decision date: 2011-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.