FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
QUANTIM 16 AUTOCLAVE
K Number: K021064
·
Decision Aug 8, 2002
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
9
Review Days
128
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Basic Information
- Device Name
- QUANTIM 16 AUTOCLAVE
- K Number
- K021064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scican
- Date Received
- April 2, 2002
- Decision Date
- August 8, 2002
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Scican
| K Number | Device Name | ||
|---|---|---|---|
| K062418 | K-SPRAY, MODEL 085-2715 | Oct 19, 2006 | Substantially Equivalent |
| K983679 | STATIM 5000 CASSETTE AUTOCLAVE | Jan 4, 1999 | Substantially Equivalent |
| K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 4, 1997 | Substantially Equivalent |
| K962179 | STAT IM 5000 CASSETTE AUTOCLAVE | Jan 13, 1997 | Substantially Equivalent |
| K944036 | STERIMASTER AUTOCLAVE | Oct 2, 1996 | Substantially Equivalent |
| K945142 | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) | Jan 11, 1995 | Substantially Equivalent |
| K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION | Aug 4, 1992 | Substantially Equivalent |
| K910241 | STATIM CASSETTE AUTOCLAVE | May 3, 1991 | Substantially Equivalent |