Baby Board
FDA 510(k) K935098 · Sentry Medical Products, Inc.
510(k) numberK935098
Submission
- Device name
- Baby Board
- Applicant
- Sentry Medical Products, Inc.
Irvine, CA, US - Received
- October 25, 1993
- Decision date
- February 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K792147 | Arm Shield for AnesthesiaBTX · Traditional | Medical Innovations Corp. | 12/06/1979SE |
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| K962122 | Sentry Radiotranslucent ECG ElectrodesDRX · Traditional | 07/24/1996SE |
| K955636 | Sentry Disposable Dispersive ElectrodeJOS · Traditional | 03/27/1996SE |
| K942827 | Sentry Insertion TrayFOS · Traditional | 11/02/1994SE |
| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | 08/30/1994SE |
| K933603 | LeadwireDSA · Traditional | 01/18/1994SE |
| K932704 | Patient CableDSA · Traditional | 12/27/1993SE |
| K881670 | Accutemp PlusFMT · Traditional | 11/22/1988SE |
| K881343 | Duraderm ButterflyGXY · Traditional | 05/04/1988SE |
| K851522 | Diagnostic ECG Disposable ElectrodeDRX · Traditional | 10/24/1985SE |
| K853552 | Sentry Flexible TENSGXY · Traditional | 09/26/1985SE |
Questions and answers
When was Baby Board cleared by the FDA?
Baby Board (K935098) received a 510(k) decision of Substantially Equivalent on February 15, 1994, 113 days after the submission was received.
What is the product code of K935098?
The FDA product code is BTX – Board, Arm (With Cover), Sterile, a Class I (low risk) device regulated under 21 CFR 878.3910.