FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISINFECTION WITH THE COX DRY HEAT STERILIZER
K Number: K910925
·
Decision May 8, 1992
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
4
Review Days
430
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISINFECTION WITH THE COX DRY HEAT STERILIZER
- K Number
- K910925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6870
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cox Sterile Products, Inc.
- Date Received
- March 5, 1991
- Decision Date
- May 8, 1992
- Product Code
- KMH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KMH | Sterilizer, Dry Heat | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMH), ordered by most recent decision date.
STERI-DENT, STERI-SURE
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX MODEL 2000
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
FDA 510(k)
FDA Class 2
·General Hospital
COX RAPID HEAT TRANSFER STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital