Hanaulux Blue 80 Hospital

FDA 510(k) K970886 · Heraeus Med GmbH

Substantially Equivalent

510(k) numberK970886

Submission

Device name
Hanaulux Blue 80 Hospital
Applicant
Heraeus Med GmbH
Hanau, DE
Received
February 6, 1997
Decision date
April 16, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSS – Light, Surgical, Floor Standing
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSS

510(k)DeviceApplicantDecision
K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated Trumpf Medizin Systeme GmbH + Co. KG09/28/2009SE
K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional Medical Illumination International, Inc.02/02/2001SE
K984124Aesculap Xenon Light SourceFSS · Traditional Aesculap, Inc.02/01/1999SE
K981962Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional Cuda Products Co.08/18/1998SE
K981821Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional Angiolaz, Inc.07/29/1998SE
K981469CERMAX300 LightsourceFSS · Traditional Cuda Products Co.07/09/1998SE
K980044Xenon 300MXFSS · Traditional Perkinelmer Optoelectronics04/03/1998SE
K961971Q-5000FSS · Traditional Stryker Endoscopy06/28/1996SE
K961074Lightsource or IlluminatorFSS · Traditional Cuda Products Co.04/30/1996SE
K930711Tri*StarFSS · Traditional Light Technology Systems07/30/1993SE

More from Light Technology Systems

510(k)DeviceDecision
K973466Hanaulux Blue 75 and Hanaulux Blue 120FSY · Traditional 10/24/1997SE
K954169Hanaulux Blue 30 & 80FSY · Traditional 02/01/1996SE

Questions and answers

When was Hanaulux Blue 80 Hospital cleared by the FDA?

Hanaulux Blue 80 Hospital (K970886) received a 510(k) decision of Substantially Equivalent on April 16, 1997, 69 days after the submission was received.

What is the product code of K970886?

The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.