CapnoSpot Pneumothorax Decompression Indicator— 510(k) K223625

Substantially Equivalent

Pneumeric, Inc.

FDA 510(k) clearance K223625 for CapnoSpot Pneumothorax Decompression Indicator, Substantially Equivalent on 2023-03-28. Applicant: Pneumeric, Inc..

Clearance details

Applicant: Pneumeric, Inc.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 2022-12-05
Decision date: 2023-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.