LIFE TRACE(R) BILIRUBIN MASK— 510(k) K926118

Name: FDA 510(k) clearance K926118
Creator: U.S. Food and Drug Administration
Published: 1993-03-15

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K926118 for LIFE TRACE(R) BILIRUBIN MASK, Substantially Equivalent on 1993-03-15. Applicant: Graphic Controls Corp.. Device class: 1.

Clearance details

Applicant: Graphic Controls Corp.
Product code: Code FOK
Device class: Class 1
Regulation: 21 CFR 880.5270
Advisory panel: General Hospital
Date received: 1992-12-03
Decision date: 1993-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOK

view all

K962290 — DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER1996-07-03
K851918 — INFANT PHOTOTHERAPY MASK1985-06-07
K840894 — PHOTO-THERAPY EYE PROTECTOR1984-03-23
K813214 — INFANT PHOTOTHERAPY MASK1981-12-09

More clearances from Graphic Controls Corp.

view all

K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE1998-11-13
K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE1998-11-05
K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)1998-07-14
K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE1998-05-12
K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE1997-08-27

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