C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A— 510(k) K041376
Substantially EquivalentAnalogic Corp.
FDA 510(k) clearance K041376 for C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A, Substantially Equivalent on 2004-07-20. Applicant: Analogic Corp.. Device class: 2.
Clearance details
- Applicant
- Analogic Corp.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Peabody, MA, US
Recent devices under product code MWI
view allMore clearances from Analogic Corp.
view all- K071430 — SYNERAD OMNI, MODELS AN6255 AND AN6265
- 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
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.