ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS— 510(k) K003492
Substantially EquivalentCambridge Heart, Inc.
FDA 510(k) clearance K003492 for ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS, Substantially Equivalent on 2001-01-18. Applicant: Cambridge Heart, Inc..
Clearance details
- Applicant
- Cambridge Heart, Inc.
- Product code
- Code DQK
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South West Ranches, FL, US
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.