BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900— 510(k) K000960
Substantially EquivalentBarzell-Whitmore Maroon Bells, Inc.
FDA 510(k) clearance K000960 for BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900, Substantially Equivalent on 2000-05-26. Applicant: Barzell-Whitmore Maroon Bells, Inc..
Clearance details
- Applicant
- Barzell-Whitmore Maroon Bells, Inc.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Appollo Beach, FL, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.