FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES
K Number: K950464
·
Decision Apr 25, 1995
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES
- K Number
- K950464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sscor
- Date Received
- February 3, 1995
- Decision Date
- April 25, 1995
- Product Code
- GCX
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Sscor
| K Number | Device Name | ||
|---|---|---|---|
| K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 | May 18, 2004 | Substantially Equivalent |
| K964997 | S-SCORT (2500) | Mar 5, 1997 | Substantially Equivalent |
| K952632 | S-SCORT | Jun 16, 1995 | Substantially Equivalent |
| K945929 | S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP | Dec 22, 1994 | Substantially Equivalent |