DANA
FDA 510(k) clearance K141865 · decided 2014-10-15
Clearance details
- K-number
- K141865
- Device name
- DANA
- Applicant
- Anthrotronix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-10
- Decision date
- 2014-10-15
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- LQD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Silver Spring, MD, US
- Third-party review
- No
- Expedited review
- No
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| OPTAX SYSTEM (K020800) | Optax Systems, Inc. | 2002-06-10 |
| DYNAVISION 2000 (K911938) | Performance Ent. | 1991-08-02 |
| FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (K861304) | Infantest Corp. | 1986-09-23 |
| GORDON DIAGNOSTIC SYSTEM MODEL I (K854903) | Clinical Diagnostics, Inc. | 1986-06-02 |
Recalls involving this device
No recalls on record reference this clearance.