PEPER— 510(k) K060297
Substantially EquivalentMedical Monitors, Ltd.
FDA 510(k) clearance K060297 for PEPER, Substantially Equivalent on 2006-08-02. Applicant: Medical Monitors, Ltd.. Device class: 2.
Clearance details
- Applicant
- Medical Monitors, Ltd.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westfield East Gardens, AU
Recent devices under product code DXH
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