RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS— 510(k) K083645
Substantially Equivalent5 Star Medical, Inc.
FDA 510(k) clearance K083645 for RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS, Substantially Equivalent on 2009-02-24. Applicant: 5 Star Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- 5 Star Medical, Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Odessa, FL, US
Recent devices under product code MQB
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