Atlas FDA

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

FDA 510(k) clearance K980756 · decided 1998-11-05

Clearance details

K-number
K980756
Device name
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
Applicant
Ge Medical Systems Information Technologies
Decision
Substantially Equivalent
Date received
1998-02-27
Decision date
1998-11-05
Days to decision
251 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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002)Ge Medical Systems Information Technologies2003-10-15
COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001)Ge Medical Systems Information Technologies2001-11-09
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016)Ge Medical Systems Information Technologies2001-02-09
MODEL 515 NEONATAL MONIOTR (P840037/S001)Ge Medical Systems Information Technologies1986-11-19