Atlas FDA

TRANSCUTANEOUS O2/CO2 MONITOR

FDA 510(k) clearance K890517 · decided 1989-04-14

Clearance details

K-number
K890517
Device name
TRANSCUTANEOUS O2/CO2 MONITOR
Applicant
Novametrix Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1989-01-30
Decision date
1989-04-14
Days to decision
74 days
Clearance type
Traditional
Product code
LKD
Device class
2
Regulation number
868.2480
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Wallingford, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 a recall (Z-1270-2010)Philips Healthcare Inc.2010-04-08
French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for trending O2 recall (Z-1271-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tensi recall (Z-1272-2010)Philips Healthcare Inc.2010-04-08
Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used for recall (Z-1288-2010)Philips Healthcare Inc.2010-04-08

PMA approvals by this applicant

RecordFirmDate
TCO2M MODEL 818 MONITOR (P810022/S014)Novametrix Medical Systems, Inc.1987-10-09
TCO2M MODEL 818 MONITOR (P810022/S013)Novametrix Medical Systems, Inc.1987-01-29
TCO2M MODEL 818 MONITOR (P810022/S012)Novametrix Medical Systems, Inc.1986-06-05
TCO2M MODEL 818 MONITOR (P810022/S011)Novametrix Medical Systems, Inc.1985-11-21
TCO2M MODEL 818 MONITOR (P810022/S009)Novametrix Medical Systems, Inc.1985-09-03
TCO2M MODEL 818 MONITOR (P810022/S010)Novametrix Medical Systems, Inc.1985-07-01
TCO2M MODEL 818 MONITOR (P810022/S008)Novametrix Medical Systems, Inc.1985-03-11
TCO2M MODEL 818 MONITOR (P810022/S007)Novametrix Medical Systems, Inc.1984-12-04