PHOENIX INFANT RADIANT WARMER, MODEL 100NWS— 510(k) K033040

Name: FDA 510(k) clearance K033040
Creator: U.S. Food and Drug Administration
Published: 2003-12-17

Substantially Equivalent

International Hospital Supply Co.

FDA 510(k) clearance K033040 for PHOENIX INFANT RADIANT WARMER, MODEL 100NWS, Substantially Equivalent on 2003-12-17. Applicant: International Hospital Supply Co.. Device class: 2.

Clearance details

Applicant: International Hospital Supply Co.
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMT

view all

K243606 — Babyroo TN3002025-01-17
K230278 — Babyroo TN3002023-05-30
K213551 — Giraffe Omnibed Carestation CS12022-03-02
K201628 — Panda iRes Warmer, Giraffe Warmer2021-02-12
K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2020-04-02

More clearances from International Hospital Supply Co.

view all

K040853 — PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 1012004-06-21
K911982 — BONE NAIL, KUNTSCHER1991-07-26
K911377 — FORCEPS, COAGULATION, BIPOLAR, MALIS1991-04-19
K910621 — BLADES FOR SPINAL LAMINECTOMY RETRACTOR1991-04-01

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.