DPZ · Class II · 21 CFR 870.2710

FDA Product Code DPZ: Oximeter, Ear

Leading manufacturers include Datex-Ohmeda, Inc., Elekon Industries U.S.A., Inc. and Bio-Tek Instruments, Inc..

11
Total
11
Cleared
74d
Avg days
1981
Since

FDA 510(k) Cleared Oximeter, Ear Devices (Product Code DPZ)

11 devices
1–11 of 11
Cleared Dec 06, 2004
FLEXI-STAT SP02 EAR SENSOR
K042675
Elekon Industries U.S.A., Inc.
Anesthesiology · 68d
Cleared Sep 02, 2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831
Datex-Ohmeda, Inc.
Anesthesiology · 155d
Cleared Oct 17, 1994
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K944760
Nellcor, Inc.
Anesthesiology · 20d
Cleared Sep 02, 1994
MARQUETTE EAR PROBE SENSOR
K942752
Marquette Electronics, Inc.
Anesthesiology · 84d
Cleared Sep 11, 1986
PULSE OXIMETER
K862426
Draeger Medical, Inc.
Anesthesiology · 77d
Cleared Mar 28, 1985
OHMEDA BIOX 3700 PULSE OXIMETER
K850494
Ohmeda Medical
Anesthesiology · 48d
Cleared Feb 27, 1981
EAR OXIMETER
K810363
Bio-Tek Instruments, Inc.
Anesthesiology · 16d

About Product Code DPZ - Regulatory Context