Cover, Armboard, Disposable
FDA 510(k) K770391 · Precept, Inc.
510(k) numberK770391
Submission
- Device name
- Cover, Armboard, Disposable
- Applicant
- Precept, Inc.
Walker, MI, US - Received
- February 28, 1977
- Decision date
- March 7, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTX – Board, Arm (With Cover), Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3910
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935098 | Baby BoardBTX · Traditional | Sentry Medical Products, Inc. | 02/15/1994SE |
| K900175 | 4/1 ArmboardBTX · Traditional | Infection Control Products, Inc. | 01/24/1990SE |
| K884838 | Allen Prone ArmboardBTX · Traditional | Edgewater Medical Systems, Inc. | 12/15/1988SE |
| K882524 | Universally Adjustable ArmboardBTX · Traditional | Karlin Technology, Inc. | 07/08/1988SE |
| K881292 | Allen Lateral ArmboardBTX · Traditional | Edgewater Medical Systems, Inc. | 04/07/1988SE |
| K864670 | Board, Arm (with Cover)BTX · Traditional | Anago, Inc. | 01/12/1987SE |
| K833664 | Armboard and the BoardBTX · Traditional | Rick Robbin & Frederick Auerbach | 12/27/1983SE |
| K830018 | Safe-T Arm BoardBTX · Traditional | Harvey A. Turner, M.D. | 01/26/1983SE |
| K823412 | Arm Board W/I.V CoveringBTX · Traditional | Sage Products, Inc. | 12/15/1982SE |
| K811419 | Sprio-LoopBTX · Traditional | Datamed, Inc. | 06/12/1981SE |
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Questions and answers
When was Cover, Armboard, Disposable cleared by the FDA?
Cover, Armboard, Disposable (K770391) received a 510(k) decision of Substantially Equivalent on March 7, 1977, 7 days after the submission was received.
What is the product code of K770391?
The FDA product code is BTX – Board, Arm (With Cover), Sterile, a Class I (low risk) device regulated under 21 CFR 878.3910.