HOLTER LX ANALYSIS— 510(k) K081861
Substantially EquivalentNorth East Monitoring, Inc.
FDA 510(k) clearance K081861 for HOLTER LX ANALYSIS, Substantially Equivalent on 2008-12-04. Applicant: North East Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- North East Monitoring, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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