PAM-RL— 510(k) K010997
Substantially EquivalentIndividual Monitoring Systems, Inc.
FDA 510(k) clearance K010997 for PAM-RL, Substantially Equivalent on 2001-10-15. Applicant: Individual Monitoring Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Individual Monitoring Systems, 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
- Baltimore, MD, US
Recent devices under product code GWQ
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