Penox Hospital Bed
FDA 510(k) K864667 · Penox Technologies, Inc.
510(k) numberK864667
Submission
- Device name
- Penox Hospital Bed
- Applicant
- Penox Technologies, Inc.
Pittston, PA, US - Received
- December 2, 1986
- Decision date
- January 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNJ – Bed, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5120
- Specialty
- General Hospital
Other 510(k)s with product code FNJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934298 | King KribFNJ · Traditional | Noritage, Inc. | 01/26/1994SE |
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | Warsaw Orthopedic, Inc. | 06/15/1989SE |
| K885241 | Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional | King Mfg. Co. | 02/24/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | Commercial Products & Engineering Co. | 11/21/1988SE |
| K881725 | Envirotent (Bed)FNJ · Traditional | Envirotents, Inc. | 11/08/1988SE |
| K881961 | Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional | Med Service, Inc. | 11/01/1988SE |
| K881964 | Msi 3003 Series BedFNJ · Traditional | Med Service, Inc. | 06/28/1988SE |
| K881962 | Msi 2005 Series BedFNJ · Traditional | Med Service, Inc. | 06/03/1988SE |
| K881043 | Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional | Junkin Safety Appliance Co., Inc. | 04/12/1988SE |
| K870166 | Platform Mattress W/Disposable Bedpan BagFNJ · Traditional | George C. Kuhn | 03/13/1987SE |
More from George C. Kuhn
| 510(k) | Device | Decision |
|---|---|---|
| K863978 | Portable Liquid Oxygen Unit (Modification)BYJ · Traditional | 12/15/1986SE |
| K862654 | Modified Penox Lift ChairINO · Traditional | 07/18/1986SE |
| K853775 | Penox High Flow ManifoldBYJ · Traditional | 11/29/1985SE |
| K852109 | Penox Performer WheelchairIOR · Traditional | 08/22/1985SE |
| K851218 | Penox Lift ChairINO · Traditional | 06/21/1985SE |
| K851219 | Fill Hose Safety AdapterCAM · Traditional | 06/18/1985SE |
| K851217 | Penox Dual Flow MinifoldCAM · Traditional | 06/18/1985SE |
| K851216 | Penox Dual Feed ManifoldCAM · Traditional | 06/18/1985SE |
| K851215 | T-Handle Adapter, U-Handle & L Handler AdapterCAM · Traditional | 06/18/1985SE |
Questions and answers
When was Penox Hospital Bed cleared by the FDA?
Penox Hospital Bed (K864667) received a 510(k) decision of Substantially Equivalent on January 21, 1987, 50 days after the submission was received.
What is the product code of K864667?
The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.