DRAGER PT4000 PHOTOTHERAPY SYSTEM— 510(k) K954611

Substantially Equivalent

Drager, Inc.

FDA 510(k) clearance K954611 for DRAGER PT4000 PHOTOTHERAPY SYSTEM, Substantially Equivalent on 1995-12-01. Applicant: Drager, Inc.. Device class: 2.

Clearance details

Applicant: Drager, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1995-10-04
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05

More clearances from Drager, Inc.

K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 41999-08-24
K984577 — DRAGER OXYLOG 20001999-01-22
K983219 — NEOFLOW OPTION MODEL NUMBERS 8413563, 84119001998-12-07
K982789 — MEDICAL AIR COMPRESSOR, MODEL # 84134191998-10-29
K980642 — EVITA 4 (8411900)1998-09-04

Recalls naming K954611

K-number listed on FDA's recall record

Z-1950-2012 — Drager PT 4000 Phototherapy SystemClass II·Terminated·Draeger Medical Systems, Inc.·20120702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954611.

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