FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEM-C
K Number: K830397
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
86
Applicant Total
5
Review Days
64
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Basic Information
- Device Name
- PEM-C
- K Number
- K830397
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Health Development Corp.
- Date Received
- February 7, 1983
- Decision Date
- April 12, 1983
- Product Code
- JSF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | FDA class 1 | Microbiology |
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Other Clearances by Health Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K823937 | SEMINAL COLLECTION DEVICE | Feb 24, 1983 | Substantially Equivalent |
| K810499 | PERCUTANEOUS GASTROINTESTINAL TUBE | Mar 4, 1981 | Substantially Equivalent |
| K802482 | KEOFEED (R) EASY-FILL ENTERIC FEED BAG | Oct 31, 1980 | Substantially Equivalent |
| K791714 | SURGIFEED | Jan 16, 1980 | Substantially Equivalent |