510(k) K861455

MODEL DT-102 DATA TELEPHONE TRANSMITTER by Advantage Medical Systems, Inc. — Product Code HGM

K861455 is an FDA 510(k) premarket notification submitted by Advantage Medical Systems, Inc. for the device "MODEL DT-102 DATA TELEPHONE TRANSMITTER". The FDA issued a decision of SN on May 30, 1986. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Advantage Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 30, 1986
Date Received
April 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type