DATA MASTER PERFUSION MONITORING SYSTEM— 510(k) K001388
Substantially EquivalentDideco
FDA 510(k) clearance K001388 for DATA MASTER PERFUSION MONITORING SYSTEM, Substantially Equivalent on 2000-07-28. Applicant: Dideco. Device class: 2.
Clearance details
- Applicant
- Dideco
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- North Attleboro, MA, US
Recent devices under product code DRY
view allMore clearances from Dideco
view allAdverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.