ACTIWATCH
FDA 510(k) clearance K983533 · decided 1999-03-23
Clearance details
- K-number
- K983533
- Device name
- ACTIWATCH
- Applicant
- Mini-Mitter Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-08
- Decision date
- 1999-03-23
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- GWQ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunriver, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Numbe recall (Z-0324-2008) | Mini-Mitter Company, Inc. | 2008-01-17 |
| Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Resp recall (Z-0326-2008) | Mini-Mitter Company, Inc. | 2008-01-17 |
| Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Numb recall (Z-0327-2008) | Mini-Mitter Company, Inc. | 2008-01-17 |