SYNERAD OMNI, MODELS AN6255 AND AN6265— 510(k) K071430
Substantially EquivalentAnalogic Corp.
FDA 510(k) clearance K071430 for SYNERAD OMNI, MODELS AN6255 AND AN6265, Substantially Equivalent on 2007-06-21. Applicant: Analogic Corp.. Device class: 2.
Clearance details
- Applicant
- Analogic Corp.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Peabody, MA, US
Recent devices under product code KPR
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view all- K052447 — SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
- K050919 — LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
- K043025 — SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
- K041434 — C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
- K041376 — C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.