FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WISP MODEL 710
K Number: K772311
·
Decision Jan 12, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
16
Review Days
24
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Basic Information
- Device Name
- WISP MODEL 710
- K Number
- K772311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Waters Assoc., Inc.
- Date Received
- December 19, 1977
- Decision Date
- January 12, 1978
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Waters Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL | Jul 27, 1981 | Substantially Equivalent |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | Oct 31, 1980 | Substantially Equivalent |
| K801852 | MRM-2 OXYGEN CONSUMPTION MONITOR | Aug 20, 1980 | Substantially Equivalent |
| K801431 | PAN-AM MYELOGRAM TRAY | Aug 12, 1980 | Substantially Equivalent |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Sep 24, 1979 | Substantially Equivalent |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | Jun 22, 1979 | Substantially Equivalent |
| K782175 | CARTRIDGE HOLDER, RCM 100 | Feb 15, 1979 | Substantially Equivalent |
| K790145 | SOLVENT DELIVERY SYSTEM | Feb 15, 1979 | Substantially Equivalent |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | Jan 29, 1979 | Substantially Equivalent |
| K781915 | DATA MODULE | Jan 10, 1979 | Substantially Equivalent |