Diagnostic Monitoring Software
Gardnerville, NV, US
DIAGNOSTIC MONITORING SOFTWARE appears in FDA device records in Gardnerville, NV. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Diagnostic Monitoring Software between 1992 and 2014. The busiest year on record is 2006, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 2006 | 3 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133014 | DMS 300-2W HOLTER ECG RECORDER | MWJ | Substantially Equivalent | |
| K062959 | DMS 300-2, 300-3 AND 300-4 | MWJ | Substantially Equivalent | |
| K062088 | PREMIER 11 HOLTER | MLO | Substantially Equivalent | |
| K062007 | DMS 300-7 | DSH | Substantially Equivalent | |
| K911615 | HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 | DQK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2028190 | 1000125423 | DIAGNOSTIC MONITORING SOFTWARE | 1517 Church St, Gardnerville, NV 89410 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain