14
PM-1157-01-07/2013
Comparison with Previous Product
The Gentle Temp 521 (MC-521-E) with the legal manufacturer of OMRON
HEALTHCARE Co., Ltd at the production location of Radiant No. 20, TaiHongRoad,
WuSong Jiang Development Zone, YuShan Town, KunShan City, Jiang Su, China, is
an substantially equivalent to a similar device MC-510-E2.
The device under registration is equivalent to the earlier registered equivalent
device in the context of its intended use, field of application, technology, quality,
reliability, main specifications, lifetime, operating and storage conditions, safety,
functional peculiarities, efficiency and other parameters.
Comparative table of the product with the Previous Model
Medical device under registration
Earlier registered analogue
Pictures of the
devices
Product
Description:
Digital Ear Thermometer
Digital Ear Thermometer
Model:
OMRON Gentle Temp 521
(MC-521-E)
Omron Gentle Temp 510 (MC-510-E2)
Sensing Unit:
Thermopile
Thermopile
Temperature
Display:
4-digit,
F display in 0.1 degree
increments
3-digit,
C display in 0.1 degree
increments
In 3 digits of +
C, every 0.1
F or
C
Measurement
Accuracy:
± 0.2
C (± 0.4
F) within 35.5
C to
42.0
C (95.9
F to 107.6
F)
± 0.3
C (± 0.5
F) for other range
± 0.2
C (± 0.4
F) within 34.0
C to
42.2
C (93.2
F to 107.9
F)