CARDISUNY 501BIII— 510(k) K901948
Substantially EquivalentGraham-Field, Inc.
FDA 510(k) clearance K901948 for CARDISUNY 501BIII, Substantially Equivalent on 1990-07-17. Applicant: Graham-Field, Inc.. Device class: 2.
Clearance details
- Applicant
- Graham-Field, Inc.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Recent devices under product code DPS
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- K924876 — TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
- K904904 — MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
- K901947 — CARDISUNY 501AB
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.