BK-7511 Brass Goniometer
FDA 510(k) K801717 · Fred Sammons, Inc.
510(k) numberK801717
Submission
- Device name
- BK-7511 Brass Goniometer
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- July 24, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQW – Goniometer, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1520
- Specialty
- Orthopedic
Other 510(k)s with product code KQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926237 | O'Brien GoniometerKQW · Traditional | Sgarlato Laboratories, Inc. | 08/02/1993SE |
| K901744 | Dobbhoff(R) Retrieval ForcepsKQW · Traditional | Biosearch Medical Products, Inc. | 07/03/1990SE |
| K870767 | The (Crom) TesterKQW · Traditional | Twin City Surgical, Inc. | 03/17/1987SE |
| K850082 | Hand Held GoniometerKQW · Traditional | Chattanooga Group, Inc. | 04/04/1985SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K812778 | The Telos EquipmentKQW · Traditional | The Telos Co. | 12/08/1981SE |
| K810441 | Universal GonimeterKQW · Traditional | Fred Sammons, Inc. | 02/27/1981SE |
| K801718 | BK-7513 Stainless Steel GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801716 | BK-7505 Radiopaque Goniometer, 8KQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801715 | BK-7497 Bulb DynamometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was BK-7511 Brass Goniometer cleared by the FDA?
BK-7511 Brass Goniometer (K801717) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 11 days after the submission was received.
What is the product code of K801717?
The FDA product code is KQW – Goniometer, Nonpowered, a Class I (low risk) device regulated under 21 CFR 888.1520.