K800231
Substantially EquivalentABCO/GRANT ALTERNATING PRESSURE PAD & UT
- Applicant
- Abco Dealers, Inc.
- Product code
- FNM
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FNM
product code FNM- Death
- 22
- Injury
- 349
- Other
- 4
- Total
- 375
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.