KMH — Sterilizer, Dry Heat Class II
FDA product code KMH covers "Sterilizer, Dry Heat", a Class II medical device regulated under 21 CFR 880.6870. Submissions are reviewed by the General Hospital panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- KMH
- Device Class
- Class II
- Regulation Number
- 880.6870
- Submission Type
- 510(k)
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K094026 | Cpac | STERI-DENT, STERI-SURE | Jul 12, 2011 |
| K051660 | Coltene/Whaledent | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Aug 4, 2005 |
| K910925 | Cox Sterile Products | DISINFECTION WITH THE COX DRY HEAT STERILIZER | May 8, 1992 |
| K910202 | Dentronix | DENTRONIX MODEL 2000 | Mar 13, 1991 |
| K880322 | Dentronix | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Jul 13, 1988 |
| K881371 | Cox Sterile Products | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Apr 13, 1988 |
| K872643 | Cox Sterile Products | COX RAPID HEAT TRANSFER STERILIZER | Oct 29, 1987 |
| K871615 | Lorvic | U. V. GERMICIDAL UNIT | Sep 11, 1987 |
| K851307 | Broadwest | INOX DRY HEAT STERILIZER | May 9, 1985 |
| K771070 | Cpac | DRY HEAT STERILIZER | Jul 14, 1977 |