SERIES 700 PATIENT MONITORS

Thermometer, Electronic, Clinical

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Series 700 Patient Monitors.

Pre-market Notification Details

Device IDK761244
510k NumberK761244
Device Name:SERIES 700 PATIENT MONITORS
ClassificationThermometer, Electronic, Clinical
Applicant SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-12-13
Decision Date1976-12-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.