WRIST ACTIGRAPH— 510(k) K854030
Substantially EquivalentAmbulatory Monitoring, Inc.
FDA 510(k) clearance K854030 for WRIST ACTIGRAPH, Substantially Equivalent on 1986-06-25. Applicant: Ambulatory Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- Ambulatory Monitoring, Inc.
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ardsley, NY, US
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