Envirotent (Bed)
FDA 510(k) K881725 · Envirotents, Inc.
510(k) numberK881725
Submission
- Device name
- Envirotent (Bed)
- Applicant
- Envirotents, Inc.
Denver, CO, US - Received
- April 22, 1988
- Decision date
- November 8, 1988
- 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 |
| 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 |
| K870310 | Vsid Medical Three-Folding BedFNJ · Traditional | China National Medicines & Health Prod. I/E Corp. | 02/10/1987SE |
Questions and answers
When was Envirotent (Bed) cleared by the FDA?
Envirotent (Bed) (K881725) received a 510(k) decision of Substantially Equivalent on November 8, 1988, 200 days after the submission was received.
What is the product code of K881725?
The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.