Heine Omega 600 Salient characteristic Brand name or equal.docx

Brand Name or Equal Worksheet (“Salient Characteristics”) Brand Name Item:

Heine Omega 600

1) Essential/significant physical, functional, or performance characteristics.

a) Compatibility – Replacement Wall Charging Indirect Ophthalmoscope.

b) Dimensions – 320 x 300 x 200 mm

c) Weight – 475 Grams

d) Industry Standard – Product Classification USA: Class II, 510k exempt

e) Purpose – Optical instrument worn on the examiner’s head to evaluate the peripheral retina.

f) Governing Body or Organization – FDA regulatory number: 866.1570 Complete generic identification – Heine Omega 600 Binocular Indirect Ophthalmoscope Set with Wall Charger - Item No: IO0HEOMEGA600WALLFG An Indirect Ophthalmoscope is an optical instrument worn on the examiner’s head in direct patient care to evaluate the peripheral retina. The Heine Omega 600 comes with a lithium polymer battery that enables it to be operated for 8 hours, a yellow/blue/red-free filter to adjust to diagnostic needs, an easily adjustable headband, and Vision boost technology that enables a 20% better view in media opacities.

Applicable model/make/catalog number – Omega 600 / Heine / Item No: IO0HEOMEGA600WALLFG Heine Omega 600 Binocular Indirect Ophthalmoscope Set with Wall Charger

2) Manufacturer name – Heine/LOMBART