FOH — Mattress, Water, Temperature Regulated Class I
FDA product code FOH covers "Mattress, Water, Temperature Regulated", a Class I medical device regulated under 21 CFR 880.5560. Submissions are reviewed by the General Hospital panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOH
- Device Class
- Class I
- Regulation Number
- 880.5560
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K954216 | olympic medical | OLYMPIC WARM-BASSINET | December 8, 1995 |
| K872876 | intl. management services | IMSI/EASY FLOAT MATTRESS | October 13, 1987 |
| K812683 | pharmaquest | NEONATE FLEXFLOAT | October 13, 1981 |
| K812681 | pharmaquest | ADULT FLEX FLOAT W/HEATER | October 8, 1981 |
| K812682 | pharmaquest | FLEXFLOAT HEATER | October 8, 1981 |
| K812684 | pharmaquest | ADULT FLEXFLOAT | October 8, 1981 |