ECLIPSE PROBE COVER

System, Imaging, Pulsed Echo, Ultrasonic

PARKER LABORATORIES, INC.

The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Eclipse Probe Cover.

Pre-market Notification Details

Device IDK953673
510k NumberK953673
Device Name:ECLIPSE PROBE COVER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange,  NJ  07050
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange,  NJ  07050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-07
Decision Date1996-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855683006869 K953673 000
10855683006354 K953673 000
10855683006347 K953673 000

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