INFANT PHOTOTHERAPY MASK— 510(k) K851918

Substantially Equivalent

Alba Health Care

FDA 510(k) clearance K851918 for INFANT PHOTOTHERAPY MASK, Substantially Equivalent on 1985-06-07. Applicant: Alba Health Care. Device class: 1.

Clearance details

Applicant: Alba Health Care
Product code: Code FOK
Device class: Class 1
Regulation: 21 CFR 880.5270
Advisory panel: General Hospital
Date received: 1985-05-02
Decision date: 1985-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valdese, NC, US

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K926118 — LIFE TRACE(R) BILIRUBIN MASK1993-03-15
K840894 — PHOTO-THERAPY EYE PROTECTOR1984-03-23
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More clearances from Alba Health Care

K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP1987-01-20
K861154 — ALBA HEALTH CARE PLAIN PACKING STRIP1986-04-15
K850881 — ALBA DRY BURN PAD1985-04-17
K850904 — ALBA DRY BURN DRESSING1985-04-17
K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING1985-03-12

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