CRITERION 60 OR PM 60

Monitor, Airway Pressure (includes Gauge And/or Alarm)

CARADYNE, LTD.

The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Criterion 60 Or Pm 60.

Pre-market Notification Details

Device IDK000959
510k NumberK000959
Device Name:CRITERION 60 OR PM 60
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville,  IN  46055
ContactPaul Dryden
CorrespondentPaul Dryden
CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville,  IN  46055
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-24
Decision Date2000-06-22

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