A10 ULTRASCOPE RECORDER

Recorder, Paper Chart

EMS MEDICAL, INC.

The following data is part of a premarket notification filed by Ems Medical, Inc. with the FDA for A10 Ultrascope Recorder.

Pre-market Notification Details

Device IDK890142
510k NumberK890142
Device Name:A10 ULTRASCOPE RECORDER
ClassificationRecorder, Paper Chart
Applicant EMS MEDICAL, INC. 302 LINDBERGH AVE. LIVERMORE,  CA  94550
ContactPAUL ULBRICH
CorrespondentPAUL ULBRICH
EMS MEDICAL, INC. 302 LINDBERGH AVE. LIVERMORE,  CA  94550
Product CodeDSF  
CFR Regulation Number870.2810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-13
Decision Date1989-02-06

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