FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OEM MULTI-VAC POWERED SUCTION PUMP
K Number: K924570
·
Decision Aug 5, 1993
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
5
Review Days
329
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OEM MULTI-VAC POWERED SUCTION PUMP
- K Number
- K924570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oem Medical Div.
- Date Received
- September 10, 1992
- Decision Date
- August 5, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCX), ordered by most recent decision date.
STRYKER CASSETTE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION INSTRUMENTATION
FDA 510(k)
FDA Class 2
·General Hospital
CHASE SUCKER
FDA 510(k)
FDA Class 2
·General Hospital
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
FDA 510(k)
FDA Class 2
·General Hospital
CURITY THORACENTESIS TRAY
FDA 510(k)
FDA Class 2
·General Hospital