ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE— 510(k) K926189
Substantially EquivalentBio Clinic Co.
FDA 510(k) clearance K926189 for ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE, Substantially Equivalent on 1993-06-24. Applicant: Bio Clinic Co..
Clearance details
- Applicant
- Bio Clinic Co.
- Product code
- Code IOQ
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ontario, CA, US
Adverse events under product code IOQ
product code IOQ- Malfunction
- 676
- Other
- 5
- Total
- 681
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.