FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUANOMICS, #MP2SF
K Number: K813048
·
Decision Dec 2, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- AQUANOMICS, #MP2SF
- K Number
- K813048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6710
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cooper-Hewitt Electric Co.
- Date Received
- October 28, 1981
- Decision Date
- December 2, 1981
- Product Code
- KMG
- 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 |
|---|---|---|---|
| KMG | Purifier, Water, Ultraviolet, Medical | FDA class 2 | General Hospital |
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Other Clearances by Cooper-Hewitt Electric Co.
| K Number | Device Name | ||
|---|---|---|---|
| K860132 | AIR CARE AIR SANITIZER | Jan 13, 1987 | Substantially Equivalent |
| K862608 | SPERTILITE PHOTOTHERAPY LAMP | Aug 6, 1986 | Substantially Equivalent for Some Indications |
| K813047 | AQUANOMICS, MINI 60L | Dec 2, 1981 | Substantially Equivalent |
| K813045 | AQUANOMICS, #SP36SF | Dec 2, 1981 | Substantially Equivalent |
| K813046 | AQUANOMICS, #HHU60 | Dec 2, 1981 | Substantially Equivalent |
| K813049 | AQUANOMICS, #HHU100 | Dec 2, 1981 | Substantially Equivalent |
| K813050 | AQUANOMICS, #MP4SF | Dec 2, 1981 | Substantially Equivalent |