Mini-Mitter Co., Inc.
Bend, OR, US
Mini-Mitter Co., Inc. appears in FDA device records in Bend, OR. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Mini-Mitter Co., Inc. between 1999 and 2004. The busiest year on record is 1999, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 3 |
| 2001 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K033534 | VITALSENSE | FLL | Substantially Equivalent | |
| K011430 | ACTIWARE-PLMS | GWQ | Substantially Equivalent | |
| K991045 | MINI-LOGGER SERIES 2000 | GWK | Substantially Equivalent | |
| K991033 | ACTIWATCH-SCORE | GWQ | Substantially Equivalent | |
| K983533 | ACTIWATCH | GWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0327-2008 | Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00. | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure. | Terminated | ||
| Z-0326-2008 | Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure. | Terminated | ||
| Z-0325-2008 | Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure. | Terminated | ||
| Z-0324-2008 | Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Mini Mitter, a Respironics Company, Bend, Oregon | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain