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FDA Product Code

FDA Product Code DPZ — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.2710

510(k) Clearances — 11 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K042675 FLEXI-STAT SP02 EAR SENSOR Elekon Industries U.S.A., Inc. 2004-12-06 Traditional PDF ↗
K040831 DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Datex-Ohmeda, Inc. 2004-09-02 Traditional PDF ↗
K012333 FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. 2001-10-17 Special PDF ↗
K010718 FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. 2001-03-23 Special PDF ↗
K944760 DURA-Y OXYGEN TRANSDUCER, EAR CLIP Nellcor, Inc. 1994-10-17 Traditional PDF ↗
K942752 MARQUETTE EAR PROBE SENSOR Marquette Electronics, Inc. 1994-09-02 Traditional PDF ↗
K914595 PULSE RATE MONITOR Fitness Quest, Inc. 1992-01-31 Traditional PDF ↗
K862426 PULSE OXIMETER Draeger Medical, Inc. 1986-09-11 Traditional PDF ↗
K845051 VITALOG PMS-8 Vitalog Corp. 1985-05-15 Traditional PDF ↗
K850494 OHMEDA BIOX 3700 PULSE OXIMETER Ohmeda Medical 1985-03-28 Traditional PDF ↗
K810363 EAR OXIMETER Bio-Tek Instruments, Inc. 1981-02-27 Traditional PDF ↗

Product code DPZ · Class II · Cardiovascular. Data: openFDA.