Product code DPZ— Cardiovascular

FDA has cleared 11 devices under product code DPZ between 1981 and 2004, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20042 clearances
• 20012 clearances
• 19942 clearances
• 19921 clearance
• 19861 clearance
• 19852 clearances
• 19811 clearance

• Epic Medical Equipment Services, Inc.2 clearances
• Vitalog Corp.1 clearance
• Ohmeda Medical1 clearance
• Nellcor, Inc.1 clearance
• Marquette Electronics, Inc.1 clearance
• Fitness Quest, Inc.1 clearance
• Elekon Industries U.S.A., Inc.1 clearance
• Draeger Medical, Inc.1 clearance
• Datex-Ohmeda, Inc.1 clearance
• Bio-Tek Instruments, Inc.1 clearance

• K042675 — FLEXI-STAT SP02 EAR SENSORElekon Industries U.S.A., Inc.·2004-12-06
• K040831 — DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.·2004-09-02
• K012333 — FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.·2001-10-17
• K010718 — FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.·2001-03-23
• K944760 — DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.·1994-10-17
• K942752 — MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.·1994-09-02
• K914595 — PULSE RATE MONITORFitness Quest, Inc.·1992-01-31
• K862426 — PULSE OXIMETERDraeger Medical, Inc.·1986-09-11
• K845051 — VITALOG PMS-8Vitalog Corp.·1985-05-15
• K850494 — OHMEDA BIOX 3700 PULSE OXIMETEROhmeda Medical·1985-03-28
• K810363 — EAR OXIMETERBio-Tek Instruments, Inc.·1981-02-27