35MM ANGIOGRAM VIEWER ANALYZER— 510(k) K821491
Substantially EquivalentBirtcher Corp.
FDA 510(k) clearance K821491 for 35MM ANGIOGRAM VIEWER ANALYZER, Substantially Equivalent on 1982-07-08. Applicant: Birtcher Corp.. Device class: 2.
Clearance details
- Applicant
- Birtcher Corp.
- Product code
- Product code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DXJ
view all- K261469 — Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).
- K212003 — ESSENZ Patient Monitor
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- K201162 — Essence 55SP Large Monitor System
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
More clearances from Birtcher Corp.
view allAdverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
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.