Hall Oscillator
FDA 510(k) K832187 · Amsco Co.
510(k) numberK832187
Submission
- Device name
- Hall Oscillator
- Applicant
- Amsco Co.
Mchenry, IL, US - Received
- July 6, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960473 | Aesculap Power System HandpieceGET · Traditional | Aesculap, Inc. | 03/07/1996SE |
| K955174 | Sodem High Speed System for Neurosurgery & Median StyernotomyGET · Traditional | Sodem Diffusion SA | 01/22/1996SE |
| K942987 | Nucleotome L KitGET · Traditional | Surgical Dynamics, Inc. | 10/30/1995SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 09/15/1995SE |
| K953432 | Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 09/14/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | Midas Rex Pneumatic Tools, Inc. | 05/26/1995SE |
| K914753 | Auto Suture(R) Articulating Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 06/11/1992SE |
| K910071 | Porta Gas Compressed Gas Cylinder CartGET · Traditional | Sen Tech Medical Corp. | 03/22/1991SE |
More from Sen Tech Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K912471 | Eagle 3000 SDSFLE · Traditional | 06/26/1992SE |
| K854922 | Amsco Polaris SLFSY · Traditional | 01/24/1986SE |
| K833187 | Hall OsteonGET · Traditional | 10/31/1983SE |
| K832945 | Eagle 2000 Sterilizer Series Gas/AeraFLF · Traditional | 10/19/1983SE |
| K832188 | Hall ReciprocatorGET · Traditional | 08/12/1983SE |
| K832186 | Hall Drill/ReamerGET · Traditional | 08/12/1983SE |
| K831086 | Ceiling Mounted SupportFQO · Traditional | 08/12/1983SE |
| K831309 | Delivery 4 TableKNC · Traditional | 06/15/1983SE |
| K823360 | Surgical LightFTD · Traditional | 12/03/1982SE |
| K811242 | Disposable Sterilization WrapFRG · Traditional | 05/21/1981SE |
Questions and answers
When was Hall Oscillator cleared by the FDA?
Hall Oscillator (K832187) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 37 days after the submission was received.
What is the product code of K832187?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.