FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCURATE MEASUREMENT DEVICE KG-AMD
K Number: K833674
·
Decision Jan 25, 1984
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
69
Review Days
99
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Basic Information
- Device Name
- ACCURATE MEASUREMENT DEVICE KG-AMD
- K Number
- K833674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sorensen Research
- Date Received
- October 18, 1983
- Decision Date
- January 25, 1984
- 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 Sorensen Research
| K Number | Device Name | ||
|---|---|---|---|
| K833673 | ACCURATE MEASUREMENT DEVICE EZ-AMD | Dec 29, 1983 | Substantially Equivalent |
| K833095 | TRANSDUCER DOME SD105 | Nov 3, 1983 | Substantially Equivalent |
| K833094 | TRANSDUCER DOME SD104 | Nov 3, 1983 | Substantially Equivalent |
| K833096 | TRANSDUCER DOME DS106 | Nov 3, 1983 | Substantially Equivalent |
| K832957 | FLOW-DIRECTED HEPARIN COATED THERMODIL | Sep 29, 1983 | Substantially Equivalent |
| K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | Aug 12, 1983 | Substantially Equivalent |
| K831939 | TALL FLOOR STAND TFS-01 | Jul 19, 1983 | Substantially Equivalent |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Jul 12, 1983 | Substantially Equivalent |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Apr 9, 1982 | Substantially Equivalent |
| K813464 | DISPOSABLE TRANSDUCER | Jan 7, 1982 | Substantially Equivalent |