ClearanceBrief
Company ยท US

Elema-Schonander, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1993. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DXYImplantable Pacemaker Pulse-Generator5
IZPProgrammer, Changer, Film/Cassette, Radiographic4
KPXChanger, Radiographic Film/Cassette2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 15, 1993K934944MPQ-42
Elema-Schonander, Inc.
IZP
Nov 20, 1990K904103SEP 90
Elema-Schonander, Inc.
IZP
Sep 4, 1990K903576PUCK 90M
Elema-Schonander, Inc.
KPX
Aug 21, 1984K842911PUCK U & UD CUTFILM CHANGERS
Elema-Schonander, Inc.
KPX
Aug 21, 1984K842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
Elema-Schonander, Inc.
IZP
Feb 21, 1984K840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &
Elema-Schonander, Inc.
IZP
Oct 12, 1979K790792PULSE GENERATOR MODEL 637
Elema-Schonander, Inc.
DXY
Jun 27, 1979K790670PULSE GENERATOR MODEL 629
Elema-Schonander, Inc.
DXY
Sep 7, 1978K781178PULSE GENERATOR MODEL 208
Elema-Schonander, Inc.
DXY
Feb 24, 1977K770005PACEMAKER 208S
Elema-Schonander, Inc.
DXY
Feb 7, 1977K770135LEAD MODIFICATION
Elema-Schonander, Inc.
DXY

Latest recalls

DateFirm and productCodeLinked 510(k)
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