Dosimetric Release
FDA 510(k) K830546 · American Hospital Supply Corp.
510(k) numberK830546
Submission
- Device name
- Dosimetric Release
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- February 22, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQT – Evacuator, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4370
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KQT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | Electro Medical Systems SA | 12/16/1996SE |
| K921451 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K921088 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K910728 | Cleanflow SystemKQT · Traditional | Mitron Technologies, Inc. | 04/01/1991SE |
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | Van-Tec, Inc. | 03/02/1988SE |
| K874493 | Bella - Vac IrrigatorKQT · Traditional | Bel-Can Industries | 02/05/1988SE |
| K860266 | Ellik EvacuatorKQT · Traditional | R. J. Ltd., Ind. | 03/05/1986SE |
| K811779 | Ross-Emerson Pump, Model 55-RKQT · Traditional | J. H. Emerson Co. | 07/13/1981SE |
| K810739 | Suction Wound Drainage DeviceKQT · Traditional | The Urology Group | 06/26/1981SE |
| K801782 | General Purpose Irrigating/Aspir Syr.KQT · Traditional | The Healthcare Group Laboratories, Inc. | 08/13/1980SE |
More from The Healthcare Group Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854739 | American Sterile Surgical Absorbent Towel · Traditional | 12/27/1985SE |
| K854759 | American Sterile Mayo Stand Tray · Traditional | 12/17/1985SE |
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
| K822754 | Ear/Ulcer SyringeKCP · Traditional | 10/04/1982SE |
Questions and answers
When was Dosimetric Release cleared by the FDA?
Dosimetric Release (K830546) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 92 days after the submission was received.
What is the product code of K830546?
The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.