Cox Rapid Heat Transfer Sterilizer
FDA 510(k) K872643 · Cox Sterile Products, Inc.
510(k) numberK872643
Submission
- Device name
- Cox Rapid Heat Transfer Sterilizer
- Applicant
- Cox Sterile Products, Inc.
Dallas, TX, US - Received
- July 6, 1987
- Decision date
- October 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMH – Sterilizer, Dry Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6870
- Specialty
- General Hospital
Other 510(k)s with product code KMH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K094026 | Steri-Dent, Steri-SureKMH · Traditional | Cpac, Inc. | 07/12/2011SE |
| K051660 | Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization SystemKMH · Traditional | Coltene/Whaledent, Inc. | 08/04/2005SE |
| K910925 | Disinfection with the Cox Dry Heat SterilizerKMH · Traditional | Cox Sterile Products, Inc. | 05/08/1992SE |
| K910202 | Dentronix Model 2000KMH · Traditional | Dentronix, Inc. | 03/13/1991SE |
| K880322 | Dentronix DDS 5000 Dry Heat Sterilization SystemKMH · Traditional | Dentronix, Inc. | 07/13/1988SE |
| K881371 | Cox Rapid Heat Transfer Sterilizer W/12 Min. CycleKMH · Traditional | Cox Sterile Products, Inc. | 04/13/1988SE |
| K871615 | U. V. Germicidal UnitKMH · Traditional | Lorvic Corp. | 09/11/1987SE |
| K851307 | Inox Dry Heat SterilizerKMH · Traditional | Broadwest Corp. | 05/09/1985SE |
| K771070 | Dry Heat SterilizerKMH · Traditional | Cpac, Inc. | 07/14/1977SE |
More from Cpac, Inc.
Questions and answers
When was Cox Rapid Heat Transfer Sterilizer cleared by the FDA?
Cox Rapid Heat Transfer Sterilizer (K872643) received a 510(k) decision of Substantially Equivalent on October 29, 1987, 115 days after the submission was received.
What is the product code of K872643?
The FDA product code is KMH – Sterilizer, Dry Heat, a Class II (moderate risk) device regulated under 21 CFR 880.6870.