Atlas FDA

SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.

FDA 510(k) clearance K880217 · decided 1988-04-25

Clearance details

K-number
K880217
Device name
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
Applicant
Ge Medical Systems Information Technologies
Decision
Substantially Equivalent
Date received
1988-01-20
Decision date
1988-04-25
Days to decision
96 days
Clearance type
Traditional
Product code
DXK
Device class
2
Regulation number
870.2330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
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