TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +— 510(k) K061780
Substantially EquivalentRozinn Electronics, Inc.
FDA 510(k) clearance K061780 for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +, Substantially Equivalent on 2006-09-15. Applicant: Rozinn Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Rozinn Electronics, Inc.
- 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
- Glendale, NY, US
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