Araluen Head Shield
FDA 510(k) K810868 · Araluen, Inc.
510(k) numberK810868
Submission
- Device name
- Araluen Head Shield
- Applicant
- Araluen, Inc.
Mchenry, IL, US - Received
- March 31, 1981
- Decision date
- May 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPP – Stretcher, Hand-Carried
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6900
- Specialty
- General Hospital
Other 510(k)s with product code FPP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030283 | Baby PodFPP · Traditional | Prism Enterprises, Inc. | 04/22/2003SE |
| K942356 | MED-EVAC-4 Medical Evacuation StretcherFPP · Traditional | Montery Bay Corp. | 07/19/1994SE |
| K940130 | Stryker Model 6110 Emergency/Pole StretcherFPP · Traditional | Stryker Corp. | 03/10/1994SE |
| K940245 | Evacu-SledFPP · Traditional | Evacu Technologies, Inc. | 02/28/1994SE |
| K924275 | Restraining StretcherFPP · Traditional | Dms | 07/27/1993SE |
| K922816 | U P Custom Design, Inc. Cot Equipment CarrierFPP · Traditional | Up Custom Design, Inc. | 07/13/1993SE |
| K924669 | Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional | Ferno | 04/29/1993SE |
| K920805 | Life Lite Emergency StretcherFPP · Traditional | Design Principles, Inc. | 05/22/1992SE |
| K915874 | Basket Litter CarrierFPP · Traditional | Bradco Med , Ltd. | 05/13/1992SE |
| K914140 | Grassi Gastrojejun Tube Gastric Decomp/Jejun FeedFPP · Traditional | Bissell Medical Products, Inc. | 03/31/1992SE |
More from Bissell Medical Products, Inc.
Questions and answers
When was Araluen Head Shield cleared by the FDA?
Araluen Head Shield (K810868) received a 510(k) decision of Substantially Equivalent on May 13, 1981, 43 days after the submission was received.
What is the product code of K810868?
The FDA product code is FPP – Stretcher, Hand-Carried, a Class I (low risk) device regulated under 21 CFR 880.6900.