510(k) K812682
- Device
- FLEXFLOAT HEATER
- Applicant
- PHARMAQUEST CORP.
- 510(k) number
- K812682
- Product code
- FOH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-08
- Date received
- 1981-09-22
- Regulation
- 880.5560
- Classification name
- Mattress, Water, Temperature Regulated
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010409218
- 3029871637
- 3015526491
- 3008058406
- 3016507522
- 3010617000
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FOH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954216 | OLYMPIC WARM-BASSINET | Olympic Medical Corp. | 1995-12-08 |
| K872876 | IMSI/EASY FLOAT MATTRESS | Intl. Management Services, Inc. | 1987-10-13 |
| K812683 | NEONATE FLEXFLOAT | Pharmaquest Corp. | 1981-10-13 |
| K812681 | ADULT FLEX FLOAT W/HEATER | Pharmaquest Corp. | 1981-10-08 |
| K812684 | ADULT FLEXFLOAT | Pharmaquest Corp. | 1981-10-08 |
Legacy Summary#
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FDA Review#
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