Universally Adjustable Armboard
FDA 510(k) K882524 · Karlin Technology, Inc.
510(k) numberK882524
Submission
- Device name
- Universally Adjustable Armboard
- Applicant
- Karlin Technology, Inc.
Marina Del Rey, CA, US - Received
- June 17, 1988
- Decision date
- July 8, 1988
- 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 |
| 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 |
| K792147 | Arm Shield for AnesthesiaBTX · Traditional | Medical Innovations Corp. | 12/06/1979SE |
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| K882525 | Spinal MicroknifeHTS · Traditional | 09/22/1988SE |
| K882519 | X-Ray MarkerJAC · Traditional | 08/09/1988SE |
| K882520 | Shoulder Bolster, Knee, Ankle & Leg Support PadsLWG · Traditional | 07/18/1988SE |
| K882073 | Spinal NeedleGDM · Traditional | 07/18/1988SE |
| K882077 | Microdiscectomy CurrettesLXH · Traditional | 06/17/1988SE |
| K882072 | Orthopaedic and Spinal Ring CurrettesJXH · Traditional | 06/17/1988SE |
| K882069 | Spinal Distractors, SpannersLXH · Traditional | 06/17/1988SE |
Questions and answers
When was Universally Adjustable Armboard cleared by the FDA?
Universally Adjustable Armboard (K882524) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 21 days after the submission was received.
What is the product code of K882524?
The FDA product code is BTX – Board, Arm (With Cover), Sterile, a Class I (low risk) device regulated under 21 CFR 878.3910.