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FDA Product Code

FDA Product Code DQA — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.2700

510(k) Clearances — 727 records · page 8 of 8

K-Number Device Name Applicant Decision Date Clearance Type Summary
K873078 NOVAMETRIX MODEL 505 PULSE OXIMETER Novametrix Medical Systems, Inc. 1987-09-23 Traditional PDF ↗
K872626 OXIMETRY MODULE Marquette Electronics, Inc. 1987-09-15 Traditional PDF ↗
K871826 PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE Datex Division Instrumentarium Corp. 1987-06-29 Traditional PDF ↗
K871864 PB240 PATIENT MONITOR/PULSE OXIMETER Puritan Bennett Corp. 1987-06-24 Traditional PDF ↗
K871353 OXIMETER Radiometer America, Inc. 1987-06-08 Traditional PDF ↗
K864730 INVIVO PULSE OXIMETER, MODEL 4500 Invivo Research Labs, Inc. 1987-05-06 Traditional PDF ↗
K870621 SATLITE/PB251 PULSE OXIMETER Datex Division Instrumentarium Corp. 1987-03-20 Traditional PDF ↗
K864279 SPACELABS MODEL 90419 PULSE OXIMETER MODULE Spacelabs, Inc. 1987-03-11 Traditional PDF ↗
K864613 502 OXYGEN SATURATION MONITOR Criticare Systems, Inc. 1987-03-04 Traditional PDF ↗
K870163 BIOCHEM MICROSPAN 1040 OXIMETER Biochem International, Inc. 1987-03-03 Traditional PDF ↗
K863918 MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT. Marquest Medical Products, Inc. 1987-01-07 Traditional PDF ↗
K863855 ACCUSAT Datascope Corp. 1987-01-06 Traditional PDF ↗
K862812 NELLCOR MVP, MODEL N-1000 Nellcor, Inc. 1986-12-22 Traditional PDF ↗
K863784 NELLCOR N-200 (PULSE OXIMETER) Nellcor, Inc. 1986-11-21 Traditional PDF ↗
K863186 BIOCHEM CO/OX 1000 Biochem International, Inc. 1986-11-07 Traditional PDF ↗
K862617 SENSORMEDICS OXYSHUTTLE(TM) Sensor Medics Corp. 1986-09-26 Traditional PDF ↗
K862798 MINIOX 100 PULSE OXIMETER Catalyst Research Corp. 1986-08-28 Traditional PDF ↗
K862161 OSC-80 OXIMETER Waters Instruments, Inc. 1986-08-18 Traditional PDF ↗
K860051 MODEL 8604 OXYGEN/PULSE MONITOR Nonin Medical, Inc. 1986-06-05 Traditional PDF ↗
K855027 PULSE OXIMETER Physio-Control Corp. 1986-05-16 Traditional PDF ↗
K844256 NELLCOR PULSE OXIMETER N-10 Nellcor, Inc. 1984-12-27 Traditional PDF ↗
K833973 MINOLTA SM-32 OXYGEN SATURATION MONIT Marquest Medical Products, Inc. 1984-05-09 Traditional PDF ↗
K833826 BTI BIOX III OXIMETER CRITICAL CAREUNI Biox Technology, Inc. 1983-12-30 Traditional PDF ↗
K822909 PULSE OXIMETER MODEL 100 Nellcor, Inc. 1982-11-01 Traditional PDF ↗
K820110 BIOX III Biox Technology, Inc. 1982-02-12 Traditional PDF ↗
K781879 HEATER, OXIMETER SYSTEM Oximetrix, Inc. 1979-01-08 Traditional PDF ↗
K780625 UNISTAT OXIMETER American Optical Corp. 1978-04-28 Traditional PDF ↗

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