FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI SURGICCAL SITE VISUALIZATION WAND
K Number: K922083
·
Decision Jan 29, 1993
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
35
Review Days
270
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Basic Information
- Device Name
- RMI SURGICCAL SITE VISUALIZATION WAND
- K Number
- K922083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Research Medical, Inc.
- Date Received
- May 4, 1992
- Decision Date
- January 29, 1993
- Product Code
- FQH
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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Other Clearances by Research Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | Jul 8, 1997 | Substantially Equivalent |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Feb 19, 1997 | Substantially Equivalent |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | Aug 13, 1996 | Substantially Equivalent |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Mar 26, 1996 | Substantially Equivalent |
| K951344 | RMI HEMOCONCENTRATOR | Aug 15, 1995 | Substantially Equivalent |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Dec 8, 1992 | Substantially Equivalent |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent |
| K901231 | RMI CARDIOPLEGIA DELIVERY KITS | Jun 8, 1990 | Substantially Equivalent |