SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER

Imager, Ultrasonic Obstetric-gynecologic

COROMETRICS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Ssd-620 Linear/convex Array Sector Scanner.

Pre-market Notification Details

Device IDK880900
510k NumberK880900
Device Name:SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
ClassificationImager, Ultrasonic Obstetric-gynecologic
Applicant COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford,  CT  06492
ContactJoseph P Lenzen
CorrespondentJoseph P Lenzen
COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford,  CT  06492
Product CodeHEM  
CFR Regulation Number884.2225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-02
Decision Date1988-06-01

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