FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE COLLECTION BOTTLE W/TUBING
K Number: K822311
·
Decision Aug 20, 1982
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
47
Review Days
17
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
- DISPOSABLE COLLECTION BOTTLE W/TUBING
- K Number
- K822311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Products
- Date Received
- August 3, 1982
- Decision Date
- August 20, 1982
- 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
Other Clearances by Ohio Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K841733 | OHIO WASTE GAS SCAVENGING RESERVOIR | Jul 11, 1984 | Substantially Equivalent |
| K842003 | OHIO WASTE GAS SCAVENGING INTERFACE | May 23, 1984 | Substantially Equivalent |
| K840356 | OHIO UNITROL II ANESTHESIA GAS MACHINE | Apr 20, 1984 | Substantially Equivalent |
| K841274 | BAG-TO-VENTILATOR SELECTOR VALVE | Apr 13, 1984 | Substantially Equivalent |
| K840967 | OHIO HEAT REFLECTING PATCH | Mar 23, 1984 | Substantially Equivalent |
| K840858 | OHIO 3300 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840857 | OHIO 3000 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840453 | MEDISHIELD PVM RESPIROMETER | Mar 2, 1984 | Substantially Equivalent |
| K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK | Feb 17, 1984 | Substantially Equivalent |
| K833335 | MODULUS II ANESTHESIA GAS MACHINE | Nov 14, 1983 | Substantially Equivalent |