FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIGAS SUCTION/DRAINAGE EQUIPMENT
K Number: K821841
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
6
Review Days
10
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Basic Information
- Device Name
- MEDIGAS SUCTION/DRAINAGE EQUIPMENT
- K Number
- K821841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Linde Div. Union Carbide Corp.
- Date Received
- June 22, 1982
- Decision Date
- July 2, 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 |
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Other Clearances by Linde Div. Union Carbide Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K882208 | MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES | Aug 3, 1988 | Substantially Equivalent |
| K882209 | MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES | Aug 2, 1988 | Substantially Equivalent |
| K882210 | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES | Jun 21, 1988 | Substantially Equivalent |
| K832143 | MARK III OXYGEN WALKER SYS. RESERVOIR | Aug 26, 1983 | Substantially Equivalent |
| K823582 | OXYGEN CONCENTRATOR UCC-100 | Jan 5, 1983 | Substantially Equivalent |