TELETOM— 510(k) K955750

Substantially Equivalent

Berchtold Holding GmbH

FDA 510(k) clearance K955750 for TELETOM, Substantially Equivalent on 1996-02-08. Applicant: Berchtold Holding GmbH.

Clearance details

Applicant: Berchtold Holding GmbH
Product code: Code FQO
Advisory panel: General, Plastic Surgery
Date received: 1995-12-18
Decision date: 1996-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.