FLEXFLOAT HEATER
FDA 510(k) clearance K812682 · decided 1981-10-08
Clearance details
- K-number
- K812682
- Device name
- FLEXFLOAT HEATER
- Applicant
- Pharmaquest Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-22
- Decision date
- 1981-10-08
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- FOH
- Device class
- 1
- Regulation number
- 880.5560
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
| IMSI/EASY FLOAT MATTRESS (K872876) | Intl. Management Services, Inc. | 1987-10-13 |
| NEONATE FLEXFLOAT (K812683) | Pharmaquest Corp. | 1981-10-13 |
| 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.