TELETOM— 510(k) K955750

Clearance details

Applicant

Berchtold Holding GmbH

Product code

Code FQO

Device class

Class 1

Regulation

21 CFR 878.4960

Advisory panel

General, Plastic Surgery

Date received

1995-12-18

Decision date

1996-02-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tuttlingen, DE

• K240598 — Maestro System (REF100)2024-06-03
• K221410 — Maestro Platform2022-12-02
• K090136 — STERIS CMAX XLT SURGICAL TABLE2009-03-20
• K972810 — OPT80 THE TRANSPORTABLE (OPT80)1997-08-26
• K971988 — ALLEN, ULTRA AND SMART SOCKETS1997-07-11

• K083066 — CHROMOPHARE E 778 AND E 5582008-10-30
• K080857 — CHROMOPHARE E-SERIES2008-04-10
• K024132 — CHROMOPHARE X 652003-03-21
• K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHT1999-07-20
• K991527 — CHROMOPHARE D500, D530, D6501999-05-27

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 →