ACTICAL
FDA 510(k) clearance K060919 · decided 2006-09-22
Clearance details
- K-number
- K060919
- Device name
- ACTICAL
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-04
- Decision date
- 2006-09-22
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- GWK
- Device class
- 2
- Regulation number
- 882.1845
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Murrysville, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oreg recall (Z-0325-2008) | Mini-Mitter Company, Inc. | 2008-01-17 |