FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT IM 5000 CASSETTE AUTOCLAVE
K Number: K962179
·
Decision Jan 13, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
9
Review Days
221
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Basic Information
- Device Name
- STAT IM 5000 CASSETTE AUTOCLAVE
- K Number
- K962179
- 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
- June 6, 1996
- Decision Date
- January 13, 1997
- 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 |
| K021064 | QUANTIM 16 AUTOCLAVE | Aug 8, 2002 | Substantially Equivalent |
| K983679 | STATIM 5000 CASSETTE AUTOCLAVE | Jan 4, 1999 | Substantially Equivalent |
| K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 4, 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 |