MODEL 510 INFANT MONITOR— 510(k) K943308

Substantially Equivalent - Subject to Tracking Reg.

Ge Medical Systems Information Technologies

FDA 510(k) clearance K943308 for MODEL 510 INFANT MONITOR, Substantially Equivalent - Subject to Tracking Reg. on 1995-07-25. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant
Ge Medical Systems Information Technologies
Product code
Code BZQ
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent - Subject to Tracking Reg.
Clearance type
Traditional
Location
Wallingford, CT, US
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