FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
K Number: K031979
·
Decision Jul 25, 2003
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
- K Number
- K031979
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Integrated Systems (Cmis)
- Date Received
- June 26, 2003
- Decision Date
- July 25, 2003
- Product Code
- FSY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Conmed Integrated Systems (Cmis)
| K Number | Device Name | ||
|---|---|---|---|
| K091648 | NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 | Aug 5, 2009 | Substantially Equivalent |
| K060717 | NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM | Apr 25, 2006 | Substantially Equivalent |
| K052740 | NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM | Oct 17, 2005 | Substantially Equivalent |
| K050829 | NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM | May 6, 2005 | Substantially Equivalent |