MODEL 500V VASCULAR SPECTRUM ANALYZER— 510(k) K882755
Substantially EquivalentMultigon Industries, Inc.
FDA 510(k) clearance K882755 for MODEL 500V VASCULAR SPECTRUM ANALYZER, Substantially Equivalent on 1988-11-29. Applicant: Multigon Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Multigon Industries, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Vernon, NY, US
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More clearances from Multigon Industries, Inc.
view all- K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
- K051739 — POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
- K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
- K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
- K863589 — MODEL 600 VASCULAR DUPLEX IMAGER
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.