Mini-Mitter Co., Inc.

Medical device manufacturer in Bend, OR.

5510(k) clearances
0PMA approvals
4recalls

Device types

510(k) clearances

510(k)DeviceDecision
K033534VitalsenseFLL · Traditional 04/22/2004SE
K011430Actiware-PlmsGWQ · Special 05/31/2001SE
K991045Mini-Logger Series 2000GWK · Traditional 09/21/1999SE
K991033Actiwatch-ScoreGWQ · Traditional 06/23/1999SE
K983533ActiwatchGWQ · Traditional 03/23/1999SE

Recalls

RecallProductInitiated
Z-0327-2008 Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part…Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which… 06/27/2007Terminated
Z-0326-2008 Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a…Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which… 06/27/2007Terminated
Z-0325-2008 Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend…Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which… 06/27/2007Terminated
Z-0324-2008 Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part…Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which… 06/27/2007Terminated