IMSI/EASY FLOAT MATTRESS
FDA 510(k) clearance K872876 · decided 1987-10-13
Clearance details
- K-number
- K872876
- Device name
- IMSI/EASY FLOAT MATTRESS
- Applicant
- Intl. Management Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-21
- Decision date
- 1987-10-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FOH
- Device class
- 1
- Regulation number
- 880.5560
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lincoln, NE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPIC WARM-BASSINET (K954216) | Olympic Medical Corp. | 1995-12-08 |
| NEONATE FLEXFLOAT (K812683) | Pharmaquest Corp. | 1981-10-13 |
| FLEXFLOAT HEATER (K812682) | Pharmaquest Corp. | 1981-10-08 |
| ADULT FLEX FLOAT W/HEATER (K812681) | Pharmaquest Corp. | 1981-10-08 |
| ADULT FLEXFLOAT (K812684) | Pharmaquest Corp. | 1981-10-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AGENASORB (P880089) | Intl. Management Services, Inc. | 1990-09-13 |