510(k) K813298

CONPHAR DELEE HILLIS STETHOSCOPE by Conphar, Inc. — Product Code HGN

K813298 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR DELEE HILLIS STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code HGN (Stethoscope, Fetal), a Class I device regulated under 21 CFR 884.2900. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1981
Date Received
November 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Fetal
Device Class
Class I
Regulation Number
884.2900
Review Panel
OB
Submission Type