MICROPHOR
FDA 510(k) clearance K913601 · decided 1994-07-15
Clearance details
- K-number
- K913601
- Device name
- MICROPHOR
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-13
- Decision date
- 1994-07-15
- Days to decision
- 1067 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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| IontoDC (K170291) | Soterix Medical, Inc. | 2017-05-01 |
| TULA Iontophoresis System with Earset (K150453) | Acclarent, Inc. | 2015-05-20 |
| HIDREX PSP1000 (K133033) | Hidrex GmbH | 2015-04-08 |
| ACTIVAPATCH ET IONTOPHORESIS PATCH (K132832) | Activatek, Inc. | 2014-02-13 |
| TULA IONTOPHORESIS SYSTEM (K110636) | Acclarent, Inc. | 2011-06-16 |
| ACTHYDERM (K083016) | Microlab Americas, Inc. | 2009-06-16 |
Recalls involving this device
No recalls on record reference this clearance.