Metron Medical Australia, Pty, Ltd.
Carrum Downs, AU
Metron Medical Australia, Pty, Ltd. appears in FDA device records in Carrum Downs, AU. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Metron Medical Australia, Pty, Ltd. between 1999 and 2013. The busiest year on record is 2001, with 6. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 6 |
| 2002 | 1 |
| 2003 | 4 |
| 2012 | 1 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132137 | MULTISTIM | IPF | Substantially Equivalent | |
| K124010 | ACCUSONIC ADVANTAGE | IMI | Substantially Equivalent | |
| K120171 | ACCUSONIC ADVANTAGE | IMI | Substantially Equivalent | |
| K030880 | VECTORSONIC, MODEL VU-270 | IMG | Substantially Equivalent | |
| K030878 | ACCOUSONIC, MODEL AS-270 | IMI | Substantially Equivalent | |
| K030648 | VECTORSURGE 5 MODEL 470 | IPF | Substantially Equivalent | |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | IMI | Substantially Equivalent | |
| K020119 | VECTORSONIC, MODEL VU-200 | IMG | Substantially Equivalent | |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | IMI | Substantially Equivalent | |
| K001897 | MULTI-STIM, MODEL MS-100 | GZJ | Substantially Equivalent | |
| K002058 | VECTORSURGE 5, MODEL VS-500 | IPF | Substantially Equivalent | |
| K010609 | ACCUSONIC, MODEL AS-260 | IMI | Substantially Equivalent | |
| K003260 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 | IPF | Substantially Equivalent | |
| K010102 | SONIC MODEL SO-300 | IMI | Substantially Equivalent | |
| K000593 | SONIC, MODEL SO-100 | IMI | Substantially Equivalent | |
| K001370 | ACCUSONIC PLUS, MODEL AP-100 | IMI | Substantially Equivalent | |
| K993821 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT | IPF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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