H59 CRITICAL CARE MONITOR— 510(k) K791839
Substantially EquivalentMedtel Pty. , Ltd.
FDA 510(k) clearance K791839 for H59 CRITICAL CARE MONITOR, Substantially Equivalent on 1979-10-01. Applicant: Medtel Pty. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Medtel Pty. , Ltd.
- Product code
- Code DSK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1110
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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