HANAULUX BLUE 80 HOSPITAL— 510(k) K970886

Clearance details

Applicant

Heraeus Med GmbH

Product code

Code FSS

Device class

Class 2

Regulation

21 CFR 878.4580

Advisory panel

General, Plastic Surgery

Date received

1997-02-06

Decision date

1997-04-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hanau, DE

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• K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE1998-08-18
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• K973466 — HANAULUX BLUE 75 AND HANAULUX BLUE 1201997-10-24
• K954169 — HANAULUX BLUE 30 & 801996-02-01

• Z-0770-2024 — Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113AClass II·Ongoing·Getinge Usa Sales Inc·20231108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970886.