CARETONE II— 510(k) K963678
Substantially EquivalentAmerican Telecare, Inc.
FDA 510(k) clearance K963678 for CARETONE II, Substantially Equivalent on 1997-02-24. Applicant: American Telecare, Inc.. Device class: 2.
Clearance details
- Applicant
- American Telecare, Inc.
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code DQD
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