Adult Flexfloat
FDA 510(k) K812684 · Pharmaquest Corp.
510(k) numberK812684
Submission
- Device name
- Adult Flexfloat
- Applicant
- Pharmaquest Corp.
Walker, MI, US - Received
- September 22, 1981
- Decision date
- October 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FOH – Mattress, Water, Temperature Regulated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5560
- Specialty
- General Hospital
Other 510(k)s with product code FOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954216 | Olympic Warm-BassinetFOH · Traditional | Olympic Medical Corp. | 12/08/1995SE |
| K872876 | Imsi/Easy Float MattressFOH · Traditional | Intl. Management Services, Inc. | 10/13/1987SE |
| K812683 | Neonate FlexfloatFOH · Traditional | Pharmaquest Corp. | 10/13/1981SE |
| K812682 | Flexfloat HeaterFOH · Traditional | Pharmaquest Corp. | 10/08/1981SE |
| K812681 | Adult Flex Float W/HeaterFOH · Traditional | Pharmaquest Corp. | 10/08/1981SE |
More from Pharmaquest Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K945519 | Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis…MPG · Traditional | 11/03/1995SE |
| K833880 | Telephonic Receiver R-10 EEGGYE · Traditional | 11/29/1983SE |
| K833236 | Telephone Transmitter T-10 EEGGYE · Traditional | 11/29/1983SE |
| K830705 | Mini Lancet-Blood LancetFMA · Traditional | 04/08/1983SE |
| K822976 | Hypocount aCGA · Traditional | 11/16/1982SE |
| K822486 | Home Blood Glucose MonitorCGA · Traditional | 11/05/1982SE |
| K820248 | Rodder Volume VentilatorCBK · Traditional | 04/16/1982SE |
| K812850 | PTT-200 Pulmonary Receiver/MicroprocesBTY · Traditional | 12/03/1981SE |
| K812849 | PTT-200 Telephonic Pulmonary TransmittBTY · Traditional | 12/03/1981SE |
| K813010 | EEG Telephone Transmitter, Model #T-7GYE · Traditional | 11/16/1981SE |
Questions and answers
When was Adult Flexfloat cleared by the FDA?
Adult Flexfloat (K812684) received a 510(k) decision of Substantially Equivalent on October 8, 1981, 16 days after the submission was received.
What is the product code of K812684?
The FDA product code is FOH – Mattress, Water, Temperature Regulated, a Class I (low risk) device regulated under 21 CFR 880.5560.