PACHPEN PACHYMETER, MODEL 24-5100

System, Imaging, Pulsed Echo, Ultrasonic

ACCUTOME, INC.

The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Pachpen Pachymeter, Model 24-5100.

Pre-market Notification Details

Device IDK050552
510k NumberK050552
Device Name:PACHPEN PACHYMETER, MODEL 24-5100
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ACCUTOME, INC. 263 GREAT VALLEY PKWY. Malvern,  PA  19355
ContactJeffrey L Wright
CorrespondentJeffrey L Wright
ACCUTOME, INC. 263 GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-03
Decision Date2005-03-28
Summary:summary

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