FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORMA CH/P GAS PROCESSOR
K Number: K812826
·
Decision Oct 23, 1981
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
11
Applicant Total
4
Review Days
15
Basic Information
- Device Name
- FORMA CH/P GAS PROCESSOR
- K Number
- K812826
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2540
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- FORMA SCIENTIFIC, INC.
- Date Received
- October 8, 1981
- Decision Date
- October 23, 1981
- Product Code
- JTQ
- 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 |
|---|---|---|---|
| JTQ | Bath, Incubators/Water, All | FDA class 1 | Microbiology |
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